KATZEN THROMBOLYSIS GUIDEWIRE
FDA 510(k) clearance K883880 · decided 1989-04-06
Clearance details
- K-number
- K883880
- Device name
- KATZEN THROMBOLYSIS GUIDEWIRE
- Applicant
- Medi-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-13
- Decision date
- 1989-04-06
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-1 recall (Z-3053-2011) | Boston Scientific Corporation | 2011-08-23 |
| Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic recall (Z-0642-2007) | Boston Scientific | 2007-03-21 |