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510(k) K042040

TRIACTIV SYSTEM by Kensey Nash Corp. — Product Code NFA

K042040 is an FDA 510(k) premarket notification submitted by Kensey Nash Corp. for the device "TRIACTIV SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 2005. The device falls under product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection), a Class II device regulated under 21 CFR 870.1250. Kensey Nash Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2005
Date Received
July 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Kensey Nash Corp.

  • K103787 — MEDEOR MATRIX (February 7, 2011)
  • K091192 — KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX (November 2, 2009)
  • K091499 — MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) (October 22, 2009)
  • K090919 — KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE (October 2, 2009)
  • K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (March 28, 2008)
  • K071695 — KENSEY NASH MACROPORE SHIELD (December 31, 2007)
  • K072384 — MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE (September 21, 2007)
  • K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM (August 23, 2007)
  • K071237 — COPIOS BONE VOID FILLER SPONGE AND PASTE (June 1, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)

Other clearances for product code NFA

  • K073523 — INTERCEPTOR PLUS CORONARY FILTER SYSTEMS (August 1, 2008)
  • K073563 — MODIFICATION TO PROXIS SYSTEM (January 31, 2008)
  • K063785 — SPIDERFX EMBOLIC PROTECTION DEVICE (January 19, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K060651 — PROXIS SYSTEM, MODEL EPS101 (September 13, 2006)
  • K052523 — PROXIS SYSTEM (September 7, 2006)
  • K062201 — SPIDERX EMBOLIC PROTECTION DEVICE (August 11, 2006)
  • K061332 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) (August 11, 2006)
  • K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM (July 11, 2006)
  • K053195 — SPIDERX EMBOLIC PROTECTION DEVICE (June 23, 2006)

FDA data resources