CATH-FINDER
FDA 510(k) clearance K931073 · decided 1994-05-05
Clearance details
- K-number
- K931073
- Device name
- CATH-FINDER
- Applicant
- Pharmacia Deltec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-02
- Decision date
- 1994-05-05
- Days to decision
- 429 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile recall (Z-0066-2007) | Smiths Medical MD, Inc. | 2006-10-24 |
| Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile recall (Z-0800-06) | Smiths Medical MD, Inc. | 2006-04-27 |
| Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile recall (Z-0801-06) | Smiths Medical MD, Inc. | 2006-04-27 |
| Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile recall (Z-0804-06) | Smiths Medical MD, Inc. | 2006-04-27 |