FDA Registration
Active
🇨🇿 Czechia
Arrow International C.R. a.s.
Reg #: 3006425876
·
FEI: 3006425876
·
Expires 2026
Products
50
Proprietary Names
258
Establishment Types
4
Classifications
50
Registration Details
- Registration Name
- Arrow International C.R. a.s.
- Registration Number
- 3006425876
- FEI Number
- 3006425876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- JAMSKA 2359/47
- City
- ZDAR NAD SAZAVOU Vysocina
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K993691
Owner / Operator
- Firm Name
- Arrow International LLC (subsidiary of Teleflex Incorporated
- Operator Number
- 2518433
- Address
- 3015 Carrington Mill Blvd.
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Divya Raman
US Agent
- Business Name
- Teleflex, Inc.
- Contact Name
- Divya Raman
- Address
- 3015 Carrington Mill Boulevard
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 612 4231738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2007-02-05 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2013-02-13 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2008-02-14 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2018-03-01 |
| Catheter, Subclavian | LFJ | Class 2 | Gastroenterology, Urology | No | 2007-12-13 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2015-11-06 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2016-01-12 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2016-01-22 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2016-04-14 |
| Multi-Lumen Hemodialysis Catheterization Kit | PPO | Class 2 | Gastroenterology, Urology | No | 2025-12-18 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2009-07-27 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2016-03-22 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-12-13 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | Class 2 | Anesthesiology | No | 2012-10-31 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2015-06-08 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2007-02-06 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2015-09-04 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2016-04-14 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2008-07-23 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2026-01-15 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2015-09-22 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2008-12-22 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2008-12-22 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2008-12-22 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2011-03-11 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2007-12-14 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2015-12-14 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 1995-02-02 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2014-02-19 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2007-12-13 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2015-09-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2009-12-17 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2010-02-09 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2016-01-21 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2016-06-30 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2010-11-19 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2015-06-26 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2016-04-25 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2010-02-08 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2008-02-15 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2008-02-15 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2016-02-05 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2024-01-25 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2016-02-29 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2015-11-05 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2016-02-29 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2010-11-19 |
Proprietary Names
Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter
ARROWg+ard Blue Plus Multi-Lumen CVC Kit
ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit
ARROWg+ard Blue Plus Two-Lumen CVC Kit
ARROWg+ard Blue Plus Two-Lumen CVC Super Kit
ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit
ARROWg+ard Blue Plus Multi-Lumen CVC Set
ARROWg+ard Blue Plus Quad-Lumen CVC Super Kit
AGB+ Two-Lumen CVC Kit
AGB+ Multi-Lumen CVC Kit
ARROWg+ard Blue Plus Quad-Lumen CVC Set
ARROWg+ard Blue Plus Quad-Lumen CVC
AGB+ Quad Lumen CVC Kit
ARROWg+ard Blue Plus Two-Lumen CVC Set
ARROWg+ard Blue Plus Two-Lumen CVC
Ag+ Blue Plus ML CVCs
none
Vessel catheterization Kit/Set
Arrow Select Kits
Arrow FlexBlock Continous Peripheral Nerve Block Kits
Hemodialysis (Acute) Products
Marked Spring-Wire Guide with Arrow Advancer
Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter
WECK
Suture, non absorbable-silk
Intravascular catheter securement
Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter
M-L CVC w/BlueFlex Tip
Drape, Surgical
Catheter Hemodialysis
Cannon Hemodialysis Catheter
VectorFlow Retrograde Replacement Hub Set
AHDC AGB KIT
NextStep Antegrade
Arrow-Clark VectorFlow Antegrade Hemodialysis Catheterization Set
VectorFlow Retrograde Chronic Hemodialysis Catheter
HEMODIALYSIS KIT
AHDC AGB U-BEND KIT
HEMODIALYSIS SET
AHDC AGB CURVED KIT
Cannon II Plus; Edge
Cannon II Plus Replacement Hub Set
NextStep Retrograde Replacement Hub Set
NextStep Retrograde
Arrow-Clark VectorFlow Retrograde Hemodialysis Catheterization Set
Arrow-Clark VectorFlow Retrograde Replacement Hub Set
NextStep Retrograde (femoral lengths)
VectorFlow Antegrade Chronic Hemodialysis Catheter
AHDC KIT
LBCVC AGB KIT
Gertie Marx
ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS
Arrow PSI
PERCUTANEOUS SHEATH INTRODUCER
Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter
FlexTip Plus Epidural Catheter
FlexTip Plus Epidural Catheterization Kit
FlexTip Plus Combined Spinal Epidural Catheterization Kit
Arrow Radial Artery
Arterial Catheter
EZ-BLOCKER
ARROW® FlexBlock Continuous Peripheral Nerve Block Sets
ARROW® FlexBlock Continuous Peripheral Nerve Block Kits
ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter
Hypodermic single lumen needle
Arrow Peripherally Inserted Central Catheter
PICC
Peripherally Inserted Central Catheter
Arrow® Arterial Catheterization Set
Pressure Injectable Peripherally Inserted Catheter
Raulerson Syringe
Arrow Raulerson Syringe
wrap, sterilzation
Arrow Continuous Nerve Block Needle
Arrow Stimulator Adapter Cable
Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile)
Arrow StimuCath® Continuous Nerve Block Set
Arrow Pressure Injectable Central Venous Catheterization Kit
Ag+ & Ag+BP Pressure Injectable CVC
Sprotte
NEW HYDROPHILIC COATING FOR WIRE GUIDES
Arrow Non-Absorbable Silk Suture
Silk Suture
LBCVC KIT
MULTILUMEN PI CVC KIT
PI CG+ PICC SET
MULTI LUMEN CVC KIT
CVC KIT
AM/AT PI MIDLINE
PI CVC SET
PI AGBA PICC KIT
ACCESS KIT
ARROW(R) VPS(R) ACCESS KIT
PICC KIT
AGBA PI MIDLINE
PREP TRAY
AGBA PICC
CVC SET
PI PICC
QUAD LUMEN PI CVC KIT
PICC SET
PI MIDLINE
PI CVC KIT
CG+ PICC SET
VESSEL CATH KIT
INTRAVENOUS SET
PREP KIT
AM PICC SET
PI CATHETER
ACCESS TRAY
PI MULTI LUMEN CVC
AGBA PI PICC KIT
PI JACC KIT
MIDLINE CATHETER KIT
Forceps
Foosin Silk Suture
Elcam Stopcock
Suture, Nonabsorbable, Synthetic, Polyamide
Arrow® 10 mL Luer-Slip Loss of Resistance Syringe
Arrow® 5 mL Luer-Slip Loss of Resistance Syringe
Preox LOR Syringe
ARROWg+ard Hemodialysis Catheters
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter
You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter
Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC)
Oxygenator, Cardiopulmonary Bypass
INTRODUCER & INJECTION NEEDLES
Arrow Central Venous Catheterization Kit
Multi-Lumen CVC
Drape, surgical
Hands-off Thermodilution Catheters
Arrow® Thermodilution Catheters
Infusion Port Thermodilution
S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS
S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS
EF-05510N: FILTER COMPONENT NRFit GVS
INSYTE INTRODUCER CATHETER
Stopcock i.v. set
StimuCath (19 Ga)
GAUZE PADS
Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter
ARROWg+ard CVCs
Heparin Coated Thermodilution Ballo
MIDLINE CATHETERS
Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter,
14 Fr 2-L Hemodialysis Catheters
You-Bend Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter
Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter
Pediatric 2-L Hemodialysis Catheter
BD ECLIPSE HYPODERMIC NEEDLE
Syringe
SUR Betha Sheet Holder
Multiple General Use
Puncture Kit, Disposable Vein
BD Eclipse Hypodermic Needle
Drape surgical
Filter Needle
Sponge
Arrowg+ard Blue Advance PICC pre-loaded with Arrow® TipTracker Stylet
Arrowg+ard Blue Advance PICC with 130 cm Hydrophilic-Coated Nitinol Guidewire
Arrowg+ard Blue Advance PICC pre-loaded with Arrow® VPS Precision Stylet
Arrowg+ard Blue Advance PICC
Arrowg+ard Blue Advance PICC Kit
Arrowg+ard Blue Advance PICC with 80 cm Hydrophilic-Coated Nitinol Guidewire
3-WAY STOPCOCK
BD Piston Syringes
Surgical Gown SMS with PE Layer
Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter
Ag+ Quad Lumen CVCs
Ag+ Super ArrowFlex PSIs
Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath
VASCUPUNCTURE PICC GUIDEWIRE
Arrow Jugular Puncture Kit
Single Lumen CVCs
instrument forceps
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
Pressure Injectable PICC
Multiple
Arrow PICC
Arrow MAC(TM) Two-Lumen Central Venous Access Kit
2-Lumen Central Venous Access (MAC)
Arrow® Epidural Needle
Arrow Epidural Anesthesia Kit
Arrow Access Tray
Arrow® Continuous Epidural Needle
Arrow Single Shot Epidural Anesthesia Kit
Single Shot Epidural Anesthesia Kit
FlexTip Plus & Accessories
Catheter Dilator
Introducer Dilator
Tissue Dilator
Arrowg+ard Blue Advance PICC pre-loaded with ARROW® VPS® Stylet
Arrow Epidural Catheterization Kit/Set with FlexTip Plus® Catheter
Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter
FlexTip Plus® Epidural Catheterization Kit for Caudal Placement
SnapLock Clamp Fastener
Arrow® SnapLock Catheter/Syringe Adapter
FlexTip Plus® Epidural Catheterization Kit
FlexTip Plus® Combined Spinal Epidural Catheterizaiton Kit
FlexTip Plus(R) Epidural Catheterization Kit for Lumbar Placement
StimuCath PNB Catheter
Arrow® Continuous Nerve Block Set
Arrow® Continuous Nerve Block Kit
Arrow Continuous Peripheral Nerve Block Kit
Arrow Prep Tray
Arrow Nerve Block Prep Tray
Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature
Arrow TheraCath® Epidural Catheter
Arrow Epidural Catheterization Kit with TheraCath® Catheter
Arrow "No Leak" Sheath Adapter with Side Port
Super Arrow-Flex® Percutaneous Sheath Introducer Set
Super ArrowFlex PSIs
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
UltraCath Continuous Nerve Block Kit
UltraCath Continuous Nerve Block Catheter
2- Lumen PICC Products w/ Blue Flex
Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and integral needle protection
Peripherally Inserted central catheter (PICC) with Blue
SWG
Dressing commercial
Guide Wire - Lake Region
Epidural Needle
Rusch Silko Spray
Anesthesia Conduct Kit
Single Shot Epidural
Mandrel Guidewires
Large Bore Multi-Lumen CVCs
Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter
Introducer, Catheter
TOURNIQUET COMMERCIAL
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device
ARROWg+ard 2-L Access (MAC)
TERUMO® SURFLO®0 IX. Catheter
3M Tegaderm +Pad Film Dressing with Non-Adherent Pad Sterile
Internal Jugular Kit
INTERLINK(TM) INJECTION SITE
Arrow Seldinger Arterial Catheterization Device
Hypodermic Needle and Syringe
RA Catheter w/Integral Ndl Protect
ARROW Radial Artery Catheterization Set with Integral Needle Protection
Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography
Arrow-Johans ECG Adapter
Becton Dickinson Syringe
wrap, sterilization
Arrow® Access Tray
Arrow Epidural Catheterization Set with FlexTip Plus® Closed Tip Multi-Port Catheter
Arrow Epidural Catheterization Kit with TheraCath®
Epidural Catheterization Kit
Arrow Epidural Catheterization Kit
Arrow Epidural Needle
Arrow Epidural Needle Kit
Spring Wire Guide
Arrow UserGard(R) Needle-Free Injection Hub
USER-GARD NEEDLESS INJECTION HUB
Arrow SharpsAwayII¿ Locking Disposal Cup
SharpsAway Needle Disposal Cups
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)