PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
FDA 510(k) clearance K955407 · decided 1996-02-12
Clearance details
- K-number
- K955407
- Device name
- PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
- Applicant
- Sims Deltec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-27
- Decision date
- 1996-02-12
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- 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 |
|---|---|---|
| Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access Syst recall (Z-2269-2013) | Smiths Medical ASD, Inc. | 2013-09-23 |