1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
FDA 510(k) clearance K983003 · decided 1998-09-17
Clearance details
- K-number
- K983003
- Device name
- 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
- Applicant
- Cordis Neurovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-28
- Decision date
- 1998-09-17
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami Lake, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to b recall (Z-0604-2009) | Cordis Corporation | 2008-12-30 |