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510(k) K060643

QL LOCKING SYRINGE by Atrion Medical Products, Inc. — Product Code MAV

K060643 is an FDA 510(k) premarket notification submitted by Atrion Medical Products, Inc. for the device "QL LOCKING SYRINGE". The FDA issued a decision of Substantially Equivalent on July 12, 2006. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Atrion Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2006
Date Received
March 10, 2006
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 Atrion Medical Products, Inc.

  • K043249 — ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (May 25, 2005)
  • K041158 — ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (June 16, 2004)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K020333 — ATRION MEDICAL QL FLUID DISPENSING SYRINGE (April 25, 2002)
  • K973633 — ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (January 16, 1998)
  • K973872 — ATRION MEDICAL COATED LACRIMAL INTUBATION SET (January 8, 1998)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K971100 — ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR (May 23, 1997)

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