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510(k) K033321

SELECTIVA SB GUIDEWIRE by Neometrics, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2003
Date Received
October 15, 2003
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

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  • K040786 — VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (April 19, 2004)
  • K031652 — VASCUPUNCTURE PICC GUIDEWIRE (September 30, 2003)

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