BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET
FDA 510(k) clearance K884129 · decided 1988-12-21
Clearance details
- K-number
- K884129
- Device name
- BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET
- Applicant
- Bio Medicus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-30
- Decision date
- 1988-12-21
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015 recall (Z-1929-2008) | Medtronic Perfusion Systems | 2008-07-24 |