FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065
K Number: K031153
·
Decision Nov 25, 2003
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
110
Review Days
228
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065
- K Number
- K031153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arrow Intl., Inc.
- Date Received
- April 11, 2003
- Decision Date
- November 25, 2003
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Elfor-L
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Arrow Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | Aug 27, 2010 | Substantially Equivalent |
| K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | Dec 18, 2009 | Substantially Equivalent |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | Oct 10, 2007 | Substantially Equivalent |
| K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | Sep 26, 2007 | Substantially Equivalent |
| K071111 | NON-ABSORBABLE SILK SUTURE | Jul 17, 2007 | Substantially Equivalent |
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | Apr 6, 2006 | Substantially Equivalent |
| K042126 | PICC | Aug 27, 2004 | Unknown |
| K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | Jul 12, 2004 | Substantially Equivalent |
| K040801 | INTRA-AORTIC BALLOON (IAB) | May 6, 2004 | Substantially Equivalent |
| K040802 | HEMOSONIC 200HEMODYNAMIC MONITOR | Apr 28, 2004 | Substantially Equivalent |