PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
FDA 510(k) clearance K871132 · decided 1987-04-20
Clearance details
- K-number
- K871132
- Device name
- PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
- Applicant
- Deltec Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-20
- Decision date
- 1987-04-20
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile recall (Z-2268-2013) | Smiths Medical ASD, Inc. | 2013-09-23 |
| 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 |
| Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile recall (Z-0807-06) | Smiths Medical MD, Inc. | 2006-04-27 |