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510(k) K962495

INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) by Advanced Cardiovascular Systems, Inc. — Product Code MAV

K962495 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)". The FDA issued a decision of Substantially Equivalent on September 12, 1996. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Advanced Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1996
Date Received
June 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Advanced Cardiovascular Systems, Inc.

  • K012534 — HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (January 24, 2002)
  • K000550 — OTW MEGALINK SDS BILIARY STENT SYSTEM (March 17, 2000)
  • K994229 — VERIPATH PERIPHERAL GUIDING CATHETER (February 25, 2000)
  • K992169 — ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE (October 28, 1999)
  • K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,100 (September 2, 1999)
  • K963702 — ACS HI-TORQUE IRON MAN GUIDE WIRE (January 22, 1997)
  • K961471 — INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 (May 8, 1996)
  • K955175 — ACS ANCHOR EXCHANGE DEVICE (April 5, 1996)
  • K953987 — ACS TOURGIDE GUIDING CATHETER (December 7, 1995)
  • K952205 — ACS POWERBASE GUILDING CATHETER (August 4, 1995)

Other clearances for product code MAV

  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K162272 — Fluent inflation device (October 20, 2016)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)
  • K130566 — BASIXTOUCH (June 19, 2013)

FDA data resources