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510(k) K022762

JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 by Jomed, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2002
Date Received
August 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Jomed, Inc.

  • K031346 — JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 (June 23, 2003)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K031277 — JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M (May 14, 2003)
  • K030053 — JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015S (March 31, 2003)
  • K021219 — SMARTWIRE/SMARTMAP PRESSURE SYSTEM (May 17, 2002)
  • K020854 — MODIFICATION TO FOX PTA CATHETER (April 11, 2002)
  • K010838 — FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A1400 (June 21, 2001)
  • K003938 — TRAK BACK II (January 18, 2001)

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