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
Phone
612 4231738

Products

Device Name Product Code
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Introducer, Catheter DYB
Catheter, Percutaneous DQY
Anesthesia Conduction Kit CAZ
Catheter, Subclavian LFJ
Bag, Intestine KGY
Suture, Nonabsorbable, Silk GAP
Device, Intravascular Catheter Securement KMK
Drape, Surgical, Antimicrobial KKX
Multi-Lumen Hemodialysis Catheterization Kit PPO
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Catheter, Conduction, Anesthetic BSO
Wire, Guide, Catheter DQX
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
Needle, Hypodermic, Single Lumen FMI
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Syringe, Piston FMF
Wrap, Sterilization FRG
Scalpel, One-Piece GDX
Peripheral Catheter Insertion Kit OWL
Forceps, General & Plastic Surgery GEN
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Stopcock, I.V. Set FMG
Catheter, Hemodialysis, Non-Implanted MPB
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Needle, Aspiration And Injection, Disposable GAA
Catheter, Intravascular, Diagnostic DQO
Catheter, Flow Directed DYG
Gauze / Sponge,Nonresorbable For External Use NAB
Instrument, Manual, Surgical, General Use MDM
Gown, Surgical FYA
Filter, Infusion Line FPB
Applicator, Absorbent Tipped, Non-Sterile KXF
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Forceps HTD
Mask, Surgical FXX
Dilator, Catheter GCC
Accessories, Catheter KGZ
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Absorbable, Natural GAL
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
Dressing, Wound, Occlusive NAD
Lubricant, Patient KMJ
Tourniquet, Nonpneumatic GAX
Tape And Bandage, Adhesive KGX
Set, Administration, Intravascular FPA
Epidural Anesthesia Kit OGE

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)