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510(k) K013664

COALESCENT SURGICAL U-CLIP by Coalescent Surgical — Product Code NCA

K013664 is an FDA 510(k) premarket notification submitted by Coalescent Surgical for the device "COALESCENT SURGICAL U-CLIP". The FDA issued a decision of Substantially Equivalent on January 24, 2002. The device falls under product code NCA (Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)), a Class II device regulated under 21 CFR 878.4300. Coalescent Surgical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2002
Date Received
November 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Coalescent Surgical

  • K040821 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES (April 23, 2004)
  • K031623 — MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (July 3, 2003)
  • K024366 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES (January 17, 2003)
  • K023125 — COALESCENT U-CLIP- AND ACCESSORIES (December 18, 2002)
  • K021407 — COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES (July 3, 2002)
  • K012317 — COALESCENT SURGICAL U-CLIP (August 31, 2001)
  • K003958 — COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE (February 6, 2001)
  • K994160 — COALESCENT SURGICAL SUTURED-CLIP (February 4, 2000)

Other clearances for product code NCA

  • K011589 — CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD ( (December 26, 2001)
  • K003446 — SYMMETRY AORTIC CLIP SYSTEM (May 21, 2001)

FDA data resources