Atlas FDA

CHASE RETROGRADE CARDIOPLEGIA CANNULA

FDA 510(k) clearance K964393 · decided 1997-04-23

Clearance details

K-number
K964393
Device name
CHASE RETROGRADE CARDIOPLEGIA CANNULA
Applicant
Chase Medical, Inc.
Decision
Substantially Equivalent
Date received
1996-11-04
Decision date
1997-04-23
Days to decision
170 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Richardson, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Chase Medical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195)Medtronic, Inc.2026-04-23
Venous Return Cannulae (K250937)LivaNova USA, Inc.2026-03-11
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (K260043)Smart Reactors2026-02-23
Retrograde Coronary Sinus Perfusion Cannulae (K253203)Medtronic, Inc.2026-02-19
Dual Stage Venous Cannulae (K253671)Sorin Group Italia S.R.L.2026-01-30
Clearview Intracoronary Shunts (K253998)Medtronic, Inc.2026-01-20
AngioVac Cannula (K253106)AngioDynamics, Inc.2025-10-24
RAP Femoral Venous Cannulae (K250283)LivaNova USA, Inc.2025-07-10
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610)Sorin Group Italia S.R.L.2025-06-27
MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (K251258)Medtronic, Inc.2025-06-20
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (K241248)Spectrum Medical S.R.L.2024-05-31
R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) (K240193)Sorin Group Italia S.R.L.2024-02-22

Recalls involving this device

RecordFirmDate
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating bal recall (Z-0892-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating bal recall (Z-0893-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions Retrograde Cardio. Cannula, 18mm self-inflating textured balloon, recall (Z-0894-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating bal recall (Z-0895-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating bal recall (Z-0896-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflati recall (Z-0897-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrog recall (Z-0898-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating tex recall (Z-0899-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18mm self-inflatin recall (Z-0900-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating bal recall (Z-0901-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflati recall (Z-0902-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflati recall (Z-0903-2007)Surge Medical Solutions, LLC2007-06-06
Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflati recall (Z-0904-2007)Surge Medical Solutions, LLC2007-06-06