Better-Tubing

510(k) Number

K964205 ↗

FDA product code

DWF

Device class

Class II

Regulation

21 CFR Part 870.4210

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

• DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS by Bentley Laboratories, Inc.
• BARD-PARKER CAROTID SHUNT by Bd Becton Dickinson Vacutainer Systems Preanalytic
• PREASSEMBLED SURGICAL WASH SET 122, 175, 225, 375AA by Shiley, Inc.
• STATFLO by Imodex, Inc.
• CHASE PHRENIC NERVE PAD by Chase Medical, Inc.
• SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER by Angiomedics, Inc.
• SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE by MEDTRONIC PERFUSION SYSTEMS
• ProtekDuo Mini Veno-Venous Cannula Set by CARDIACASSIST, INC.
• X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS by Terumo Cardiovascular Systems Corporation
• RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA by Edwards Lifesciences LLC

• Better-Bladder BB14 Open recall

  Class II

  FDA 510(k) K981284 Active Cleared 12 Aug 1998 GUDID on market

• Bigger Better-Bladder BBB38 Open recall

  Class II

  FDA 510(k) K981284 Active Cleared 12 Aug 1998 GUDID on market

• The V Bag, Catalog Number VB1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog Number VACBOX1500

  Class II

  FDA 510(k) K012942 Active Cleared 5 Nov 2001

• Initary Better Bladder-Pediatric

  Class II

  FDA 510(k) K140321 Active Cleared 17 Apr 2014

See all devices from Circulatory Technology, Inc. →