ACS INDEFLATOR P/T 20
FDA 510(k) clearance K883452 · decided 1988-10-14
Clearance details
- K-number
- K883452
- Device name
- ACS INDEFLATOR P/T 20
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-12
- Decision date
- 1988-10-14
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, 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 |
|---|---|---|
| CORONARY DILATATION CATHETERS (P810046/S240) | Advanced Cardiovascular Systems, Inc. | 2010-10-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237) | Advanced Cardiovascular Systems, Inc. | 2010-06-01 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238) | Advanced Cardiovascular Systems, Inc. | 2010-05-13 |
| SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC (P810046/S236) | Advanced Cardiovascular Systems, Inc. | 2010-04-23 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S234) | Advanced Cardiovascular Systems, Inc. | 2010-03-26 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232) | Advanced Cardiovascular Systems, Inc. | 2010-02-04 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230) | Advanced Cardiovascular Systems, Inc. | 2009-07-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231) | Advanced Cardiovascular Systems, Inc. | 2009-05-26 |