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510(k) K021219

SMARTWIRE/SMARTMAP PRESSURE SYSTEM by Jomed, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2002
Date Received
April 17, 2002
Clearance Type
Special
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)
  • K022762 — JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG14 (December 16, 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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