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510(k) K954201

BUONAFEDE PNEUMATIC SLEEVE by Promedic, Inc. — Product Code KCY

K954201 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "BUONAFEDE PNEUMATIC SLEEVE". The FDA issued a decision of Substantially Equivalent on November 9, 1995. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Promedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1995
Date Received
September 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type

Other clearances by Promedic, Inc.

  • K131889 — EUM 100PRO (April 23, 2014)
  • K112318 — CLEARPATH 24 (June 29, 2012)
  • K072756 — NON-IV ADAPTER FOR INFANT NG TUBE (December 19, 2007)
  • K060497 — BABYAIR (July 11, 2006)
  • K060842 — REVJET TURBO (June 21, 2006)
  • K052903 — PEDIATRIC FEEDING TUBE (November 9, 2005)
  • K031409 — URINARY CATHETERS (June 17, 2003)
  • K024190 — FENESTRATED INFUSION CATHETER (March 17, 2003)
  • K023579 — GAS SAMPLING LINES (January 28, 2003)
  • K020005 — INFANT FEEDING TUBES (July 16, 2002)

Other clearances for product code KCY

  • K202919 — ATS 5000 Automatic Tourniquet Instrument (May 20, 2021)
  • K162365 — T-Cuff (February 16, 2017)
  • K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (August 9, 2013)
  • K112874 — EZ VEIN INFLATABLE TOURNIQUET (October 17, 2011)
  • K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (June 7, 2007)
  • K050411 — ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (September 2, 2005)
  • K012632 — TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (October 26, 2001)
  • K955552 — EXPRESSAIRE TORUNIQUET SYSTEM (January 5, 1996)
  • K954103 — TOURNI-COMP (November 1, 1995)
  • K953953 — DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF (September 29, 1995)

FDA data resources