The following data is part of a premarket notification filed by Bypass Ltd. with the FDA for 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.
| Device ID | K011589 |
| 510k Number | K011589 |
| Device Name: | 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 |
| Classification | Clip, Implantable, For Coronary Artery Bypass Graft (cabg) |
| Applicant | BYPASS LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BYPASS LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Product Code | NCA |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-23 |
| Decision Date | 2001-12-26 |
| Summary: | summary |