CATHETER,PERCUTANEOUS INTRODUC. & SHEATH
FDA 510(k) clearance K770561 · decided 1977-04-26
Clearance details
- K-number
- K770561
- Device name
- CATHETER,PERCUTANEOUS INTRODUC. & SHEATH
- Applicant
- Usci, Div. C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-23
- Decision date
- 1977-04-26
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, 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 |
|---|---|---|
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S006) | Usci, Div. C.R. Bard, Inc. | 1997-02-04 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S005) | Usci, Div. C.R. Bard, Inc. | 1996-11-26 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S004) | Usci, Div. C.R. Bard, Inc. | 1995-06-14 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S003) | Usci, Div. C.R. Bard, Inc. | 1995-05-17 |
| USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM (P890048) | Usci, Div. C.R. Bard, Inc. | 1991-04-17 |