FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K Number: K911876
·
Decision Aug 9, 1991
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
174
Review Days
102
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
- SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
- K Number
- K911876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shiley, Inc.
- Date Received
- April 29, 1991
- Decision Date
- August 9, 1991
- 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 Shiley, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920594 | SHILEY PERFUSION TUBING SETS | Mar 18, 1993 | Substantially Equivalent |
| K910991 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM | Nov 27, 1991 | Substantially Equivalent |
| K910923 | BCD ADVANCED | Apr 9, 1991 | Substantially Equivalent |
| K901548 | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS | Jan 14, 1991 | Substantially Equivalent |
| K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | Oct 2, 1990 | Substantially Equivalent |
| K901624 | SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. | Jul 3, 1990 | Substantially Equivalent |
| K901250 | PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR | Jun 11, 1990 | Substantially Equivalent |
| K901249 | PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR | Jun 11, 1990 | Substantially Equivalent |
| K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | May 10, 1990 | Substantially Equivalent |
| K900548 | SHILEY PHONATION VALVE | Apr 23, 1990 | Substantially Equivalent |