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510(k) K143135

Spring Coil Guidewire by Neometrics, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2015
Date Received
October 31, 2014
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 Neometrics, Inc.

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  • K123439 — NEO ERCP GUIDEWIRE (January 3, 2013)
  • K101729 — NEOWIRE PTA/PTCA GUIDEWIRE (September 23, 2010)
  • K070150 — VASCUPUNCTURE PICC GUIDEWIRE (February 15, 2007)
  • K043398 — MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (March 1, 2005)
  • K040786 — VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (April 19, 2004)
  • K033321 — SELECTIVA SB GUIDEWIRE (November 5, 2003)
  • K031652 — VASCUPUNCTURE PICC GUIDEWIRE (September 30, 2003)

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