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510(k) K953522

USCI IDEAL PTCA KIT by Ryder Intl. Corp. — Product Code MAV

K953522 is an FDA 510(k) premarket notification submitted by Ryder Intl. Corp. for the device "USCI IDEAL PTCA KIT". The FDA issued a decision of Substantially Equivalent on April 17, 1996. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Ryder Intl. Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1996
Date Received
July 27, 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 Ryder Intl. Corp.

  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K962151 — RYDER LACRIMAL INTUBATIONSET (September 18, 1996)
  • K920064 — OPTI-LENS CONTACT LENS CASE (March 4, 1992)
  • K915082 — OPTI-LENS(TM) CONTACT LENS CASE (January 13, 1992)
  • K881981 — ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM (August 2, 1988)
  • K870278 — CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695 (February 20, 1987)
  • K853727 — KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) (February 7, 1986)
  • K853728 — KESTREL CONTACT LENS STORAGE CASE(NORYL) (December 13, 1985)
  • K853729 — KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) (December 13, 1985)

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