LEOCOR,INC. MODELS 1
FDA premarket approval P890001 · decided 1990-03-30
Approval details
- PMA number
- P890001
- Trade name
- LEOCOR,INC. MODELS 1
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Leocor, Inc.
- Date received
- 1989-02-09
- Decision date
- 1990-03-30
- Days to decision
- 414 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Houston, TX
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEOCOR CORFLO PUMP -- MODIFICATION (K924110) | Leocor, Inc. | 1992-09-01 |
| LEOCOR GUIDING CATHETER (K911270) | Leocor, Inc. | 1992-01-17 |
| LEOCOR CORFLO(TM) PUMP (K900350) | Leocor, Inc. | 1990-07-17 |