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510(k) K010450

LIVER TAMPONADE BALLOON by Cook, Inc. — Product Code NGU

K010450 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "LIVER TAMPONADE BALLOON". The FDA issued a decision of Substantially Equivalent on September 6, 2001. The device falls under product code NGU (Balloon, Liver Tamponade), a Class II device regulated under 21 CFR 876.5980. Cook, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2001
Date Received
February 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Liver Tamponade
Device Class
Class II
Regulation Number
876.5980
Review Panel
SU
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)
  • 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)

FDA data resources