PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
FDA 510(k) clearance K021591 · decided 2002-05-22
Clearance details
- K-number
- K021591
- Device name
- PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
- Applicant
- Cordis Neurovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-15
- Decision date
- 2002-05-22
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami Lake, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. recall (Z-1482-06) | Cordis Neurovascular, Inc. | 2006-09-02 |
| Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters. recall (Z-1483-06) | Cordis Neurovascular, Inc. | 2006-09-02 |