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510(k) K122091

COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY by Cook, Inc. — Product Code MPB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 29, 2013
Date Received
July 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Non-Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
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)

Other clearances for product code MPB

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  • K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurk (January 17, 2020)
  • K163458 — Zenysis Short-Term Dialysis Catheter (April 4, 2017)
  • K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (January 6, 2017)
  • K153190 — Zenysis Short-Term Dialysis Catheter (January 5, 2016)
  • K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (April 4, 2012)
  • K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI (December 16, 2011)
  • K102833 — DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (November 18, 2011)