PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
FDA 510(k) clearance K003925 · decided 2001-01-08
Clearance details
- K-number
- K003925
- Device name
- PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
- Applicant
- Cordis Neurovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-20
- Decision date
- 2001-01-08
- Days to decision
- 19 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 |
|---|---|---|
| Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD recall (Z-0018-04) | Cordis Neurovascular, Inc. | 2003-10-15 |