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510(k) K871982

TOURNIQUET PRESSURE REGULATOR by Avec Scientific Design Corp. — Product Code KCY

K871982 is an FDA 510(k) premarket notification submitted by Avec Scientific Design Corp. for the device "TOURNIQUET PRESSURE REGULATOR". The FDA issued a decision of Substantially Equivalent on June 9, 1987. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Avec Scientific Design Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1987
Date Received
May 22, 1987
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 Avec Scientific Design Corp.

  • K883295 — CHOP SPINE FRAME (August 23, 1988)
  • K874494 — KAMBIN LAMINECTOMY FRAME (November 23, 1987)
  • K872544 — IRRIGATION PRESSURE MONITOR (September 4, 1987)
  • K871981 — BILATERAL CONTINUOUS PASSIVE MOTION DEVICE (June 17, 1987)
  • K871900 — OVER DRAPE LEG HOLDER (June 16, 1987)

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)
  • K954201 — BUONAFEDE PNEUMATIC SLEEVE (November 9, 1995)
  • K954103 — TOURNI-COMP (November 1, 1995)

FDA data resources