PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
FDA 510(k) clearance K974471 · decided 1998-01-22
Clearance details
- K-number
- K974471
- Device name
- PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
- Applicant
- Sims Deltec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-26
- Decision date
- 1998-01-22
- Days to decision
- 57 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 |
|---|---|---|
| PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1 recall (Z-1073-2018) | Smiths Medical ASD Inc. | 2018-03-15 |
| Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual recall (Z-0877-04) | Deltec, Inc | 2004-07-20 |
| Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual recall (Z-0878-04) | Deltec, Inc | 2004-07-20 |