PTCA BALLOON CATHETERS & ACCESS.
FDA 510(k) clearance K834433 · decided 1984-04-24
Clearance details
- K-number
- K834433
- Device name
- PTCA BALLOON CATHETERS & ACCESS.
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-07
- Decision date
- 1984-04-24
- Days to decision
- 139 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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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 |