510(k) K013664
- Device
- COALESCENT SURGICAL U-CLIP
- Applicant
- COALESCENT SURGICAL
- 510(k) number
- K013664
- Product code
- NCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-24
- Date received
- 2001-11-06
- Regulation
- 878.4300
- Classification name
- Clip, Implantable, For Coronary Artery Bypass Graft (cabg)
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL A DANIEL
- Address
- 559 E. Weddell Dr. Sunnyvale CA US 94089 94089
Source Documents#
Other 510(k) Records For Product Code NCA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011589 | CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M | Bypass , Ltd. | 2001-12-26 |
| K003446 | SYMMETRY AORTIC CLIP SYSTEM | St. Jude Medical Cardiovascular Group, Inc. | 2001-05-21 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases