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510(k) K792441

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY by Edwards Laboratories — Product Code KRH

K792441 is an FDA 510(k) premarket notification submitted by Edwards Laboratories for the device "CARPENTIER-EDWARDS FLEX. ANNULOPLASTY". The FDA issued a decision of PT on March 17, 1980. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
PT ()
Decision Date
March 17, 1980
Date Received
November 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
Review Panel
CV
Submission Type

Other clearances by Edwards Laboratories

  • K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR (July 28, 1980)
  • K800655 — MODEL 100 SPECTRAVIEW (April 16, 1980)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)
  • K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A (February 26, 1979)
  • K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS (January 15, 1979)
  • K781535 — AC ADAPTER:MODELS 9525,9526,9527 (September 15, 1978)
  • K771663 — PROBE & CATHETER (September 20, 1977)
  • K771046 — VENA CAVA UMBRELLA FILTER, MODEL 7321 (June 22, 1977)
  • K760151 — APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) (August 26, 1976)
  • K760192 — COMPUTER, THERMODILUTION CARDIAC (9520) (July 19, 1976)

Other clearances for product code KRH

  • K261707 — MEMO 4D Curve™ Semirigid mitral annuloplasty ring (June 18, 2026)
  • K260498 — TriMemo™ SEMIRIGID ANNULOPLASTY RING (April 14, 2026)
  • K253232 — Seguin Annuloplasty Ring (October 29, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (July 25, 2025)
  • K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (April 9, 2024)
  • K230679 — WellsForm Tricuspid Annuloplasty Band (WF) (May 26, 2023)
  • K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring (April 7, 2023)
  • K202253 — TruForm Sievers Annuloplasty Ring (October 6, 2020)

FDA data resources