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510(k) K132020

ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER by Cook, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2013
Date Received
July 1, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Cook, Inc.

  • K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (January 9, 2015)
  • K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (December 15, 2014)
  • K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (October 9, 2014)
  • K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUT (April 18, 2014)
  • 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)
  • K131201 — ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GAST (October 7, 2013)
  • K131206 — COOK CERVICAL RIPENING BALLOON (September 27, 2013)
  • K132334 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (August 16, 2013)

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