Home / 510(k) Clearances / K955869

510(k) K955869

SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE by Scimed Life Systems, Inc. — Product Code MAV

K955869 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on March 22, 1996. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Scimed Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1996
Date Received
December 26, 1995
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 Scimed Life Systems, Inc.

  • K974241 — SCIMED INFORMER PRESSURE WIRE SYSTEM (November 12, 1998)
  • K981788 — SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER (August 18, 1998)
  • K980360 — SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES (April 29, 1998)
  • K974559 — SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (February 23, 1998)
  • K974684 — SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER (February 19, 1998)
  • K973945 — LUGE GUIDE WIRE (January 12, 1998)
  • K970823 — SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER (June 3, 1997)
  • K964551 — CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, (May 21, 1997)
  • K970244 — SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES (March 28, 1997)
  • K965023 — CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE (March 4, 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