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510(k) K904275

MORSE BALLOON INFLATION DEVICE by North American Instrument Corp. — Product Code MAV

K904275 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "MORSE BALLOON INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on January 3, 1991. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1991
Date Received
September 18, 1990
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 North American Instrument Corp.

  • K960801 — SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) (March 29, 1996)
  • K955554 — HEMO-VALVE (March 4, 1996)
  • K960310 — EPIC INTRODUCER SHEATH (February 7, 1996)
  • K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS (March 3, 1993)
  • K915078 — MORSE HEMOSTATIC CATHETER INTRODUCER SET (June 10, 1992)
  • K905208 — MORSE ANESTHESIA (January 10, 1992)
  • K912961 — MORSE VASCULAR INTRODUCER SET (September 11, 1991)
  • K910764 — THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (April 22, 1991)
  • K903493 — NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (March 26, 1991)
  • K903606 — GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER (September 27, 1990)

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