GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE
FDA 510(k) clearance K851080 · decided 1985-06-20
Clearance details
- K-number
- K851080
- Device name
- GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE
- Applicant
- G V Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-18
- Decision date
- 1985-06-20
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, 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 |
|---|---|---|
| LASTAC SYSTEM (P870071/S008) | G V Medical, Inc. | 1991-08-06 |
| LASTAC SYSTEM (P870071/S006) | G V Medical, Inc. | 1991-06-25 |
| LASTAC SYSTEM (P870071/S007) | G V Medical, Inc. | 1991-02-08 |
| LASTAC SYSTEM (P870071/S003) | G V Medical, Inc. | 1989-04-06 |
| LASTAC SYSTEM (P870071/S002) | G V Medical, Inc. | 1989-04-04 |
| LASTAC SYSTEM (P870071/S005) | G V Medical, Inc. | 1989-03-31 |
| LASTAC SYSTEM (P870071/S004) | G V Medical, Inc. | 1989-03-30 |
| LASTAC SYSTEM (P870071/S001) | G V Medical, Inc. | 1989-02-02 |