510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011589Substantially Equivalent

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., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011589 is the FDA 510(k) clearance record 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, a class II device, cleared for Bypass , Ltd. on under FDA product code NCA (Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)). FDA records list 2 510(k) clearances for Bypass , Ltd., from to . As of , FDA records show no recalls naming K011589.

Clearance record

Decision date
Received
(217 days to decision)
Product code
NCA Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bypass , Ltd. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code NCA

Trailing 12 months

FDA records hold no clearances under product code NCA in the trailing twelve months.

FDA records show no clearances under product code NCA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260