LEOCOR GUIDING CATHETER
FDA 510(k) clearance K911270 · decided 1992-01-17
Clearance details
- K-number
- K911270
- Device name
- LEOCOR GUIDING CATHETER
- Applicant
- Leocor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-22
- Decision date
- 1992-01-17
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LEOCOR SABLE(TM) PTCA CATHETER (P890001/S018) | Leocor, Inc. | 1997-06-11 |
| LEOCOR PICO-ST (P890001/S019) | Leocor, Inc. | 1997-06-09 |
| LEOCOR SABLE(TM) PTCA CATHETER (P890001/S020) | Leocor, Inc. | 1997-01-16 |
| LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S016) | Leocor, Inc. | 1996-09-17 |
| LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP (P890001/S011) | Leocor, Inc. | 1996-06-13 |
| LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED) (P890001/S014) | Leocor, Inc. | 1996-06-13 |
| LEOCOR PICO RUNNER(TM) PTCA CATHETER (P890001/S015) | Leocor, Inc. | 1996-06-07 |
| LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S012) | Leocor, Inc. | 1995-04-27 |