GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
FDA 510(k) clearance K022880 · decided 2002-09-13
Clearance details
- K-number
- K022880
- Device name
- GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-30
- Decision date
- 2002-09-13
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lafayette, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular recall (Z-0940-2011) | Maquet Cardiovascular, LLC | 2011-02-01 |