GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
FDA 510(k) clearance K024071 · decided 2003-02-14
Clearance details
- K-number
- K024071
- Device name
- GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
- Applicant
- Guidant Corporation, Cardiac Surgery
- Decision
- Substantially Equivalent
- Date received
- 2002-12-10
- Decision date
- 2003-02-14
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- NHW
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Guidant Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K020701) | Guidant Corporation, Cardiac Surgery | 2002-05-24 |
Recalls involving this device
No recalls on record reference this clearance.