LEOCOR PICO RUNNER(TM) PTCA CATHETER
FDA premarket approval P890001/S015 · decided 1996-06-07
Approval details
- PMA number
- P890001
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LEOCOR PICO RUNNER(TM) PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Leocor, Inc.
- Date received
- 1995-12-01
- Decision date
- 1996-06-07
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR AN EXTENSION OF THE LEOCOR PICO RUNNER PTCA CATHETER LINE TO INCLUDE A 4.0MM BALLOON DIAMETER
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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 |