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510(k) K122940

ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 by Cook, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2013
Date Received
September 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K131772 — CANTATA(R) 2.9 MICROCATHETER (February 20, 2014)
  • K131204 — ADVANCE CS CORONARY SINUS INFUSION CATHETER (January 29, 2014)
  • K133634 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (December 23, 2013)
  • K132020 — ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (October 25, 2013)
  • K131201 — ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GAST (October 7, 2013)
  • K131206 — COOK CERVICAL RIPENING BALLOON (September 27, 2013)

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