510(k) K020701
- Device
- SYNCRUS INTERNAL CARDIOVERSION SYSTEM
- Applicant
- GUIDANT CORPORATION, CARDIAC SURGERY
- 510(k) number
- K020701
- Product code
- NHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-24
- Date received
- 2002-03-04
- Regulation
- 870.3680
- Classification name
- Electrode, Pacing And Cardioversion, Temporary, Epicardial
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBBIE COGAN
- Address
- 3200 Lakeside Dr. Santa Clara CA US 95054 95054
Source Documents#
Other 510(k) Records For Product Code NHW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K024071 | GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM | Guidant Corporation, Cardiac Surgery | 2003-02-14 |
Legacy Summary#
summary
FDA Review#
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