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510(k) K001440

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2000
Date Received
May 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Genzyme Surgical Product (Genzyme Biosurgery)

  • K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGIC (June 12, 2000)
  • K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (September 3, 1999)
  • K991416 — ENDOSCOPIC CAMERA (July 20, 1999)
  • K991191 — BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (June 22, 1999)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K982712 — RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 (December 18, 1998)
  • K980016 — MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (August 7, 1998)
  • K981322 — CUTALON NYLON POLYAMIDE SURGICAL SUTURE (July 7, 1998)

Other clearances for product code GAT

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  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)