SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
FDA 510(k) clearance K943739 · decided 1994-11-15
Clearance details
- K-number
- K943739
- Device name
- SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
- Applicant
- Mallinckrodt Medical
- Decision
- Substantially Equivalent
- Date received
- 1994-08-02
- Decision date
- 1994-11-15
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G recall (Z-0045-2014) | Merit Medical Systems, Inc. | 2013-10-22 |
| Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic cath recall (Z-1408-2013) | Merit Medical Systems, Inc. | 2013-05-25 |
| UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medic recall (Z-0158-04) | Merit Medical Systems, Inc | 2003-11-27 |
| UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, recall (Z-0159-04) | Merit Medical Systems, Inc | 2003-11-27 |