FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
K Number: K003551
·
Decision Jul 11, 2001
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
13
Review Days
236
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
- VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
- K Number
- K003551
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jostra AG
- Date Received
- November 17, 2000
- Decision Date
- July 11, 2001
- Product Code
- DTN
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTN), ordered by most recent decision date.
Inspire HCR and HCR DUAL cardiotomy reservoirs
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Hybrid System
FDA 510(k)
FDA Class 2
·Cardiovascular
MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL
FDA 510(k)
FDA Class 2
·Cardiovascular
BMR 1900 PHISIO
FDA 510(k)
FDA Class 2
·Cardiovascular
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Jostra AG
| K Number | Device Name | ||
|---|---|---|---|
| K020983 | JOSTRA SUCKERS, MODEL JS | Jan 30, 2004 | Substantially Equivalent |
| K030264 | QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 | Feb 26, 2003 | Substantially Equivalent |
| K020784 | JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS | Jan 9, 2003 | Substantially Equivalent |
| K023132 | JOSTRA MECC SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K022022 | JOSTRA VENT CATHETERS, MODELS LV & HKV | Sep 11, 2002 | Substantially Equivalent |
| K020515 | JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA | Apr 24, 2002 | Substantially Equivalent |
| K014303 | JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE | Mar 26, 2002 | Substantially Equivalent |
| K013944 | JOSTRA DUAL STAGE VENOUS RETURN CANNULAE | Feb 11, 2002 | Substantially Equivalent |
| K013939 | JOSTRA FLOWPROBE FP-32E | Dec 14, 2001 | Substantially Equivalent |
| K012774 | JOSTRA ARTERIAL PERFUSION CANNULAE | Nov 16, 2001 | Substantially Equivalent |