Atlas FDA

SARNS CARDIOPLEGIA/VENT CATHETERS

FDA 510(k) clearance K873212 · decided 1987-11-06

Clearance details

K-number
K873212
Device name
SARNS CARDIOPLEGIA/VENT CATHETERS
Applicant
3M Health Care, Sarns
Decision
Substantially Equivalent
Date received
1987-08-14
Decision date
1987-11-06
Days to decision
84 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ann Arbor, MI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch 3M Health Care

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
Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEED recall (Z-1875-2012)Terumo Cardiovascular Systems Corporation2012-06-27
SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NE recall (Z-1876-2012)Terumo Cardiovascular Systems Corporation2012-06-27
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,REC recall (Z-1877-2012)Terumo Cardiovascular Systems Corporation2012-06-27
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECT recall (Z-1878-2012)Terumo Cardiovascular Systems Corporation2012-06-27
FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are recall (Z-1879-2012)Terumo Cardiovascular Systems Corporation2012-06-27
INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Cat recall (Z-1880-2012)Terumo Cardiovascular Systems Corporation2012-06-27
XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia recall (Z-1881-2012)Terumo Cardiovascular Systems Corporation2012-06-27
X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Ve recall (Z-1882-2012)Terumo Cardiovascular Systems Corporation2012-06-27
X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia recall (Z-1883-2012)Terumo Cardiovascular Systems Corporation2012-06-27
X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia recall (Z-1884-2012)Terumo Cardiovascular Systems Corporation2012-06-27
MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/ recall (Z-1885-2012)Terumo Cardiovascular Systems Corporation2012-06-27
X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Ve recall (Z-1886-2012)Terumo Cardiovascular Systems Corporation2012-06-27
X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/ recall (Z-1887-2012)Terumo Cardiovascular Systems Corporation2012-06-27
CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia recall (Z-1888-2012)Terumo Cardiovascular Systems Corporation2012-06-27
CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegi recall (Z-1889-2012)Terumo Cardiovascular Systems Corporation2012-06-27
CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/V recall (Z-1890-2012)Terumo Cardiovascular Systems Corporation2012-06-27
CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardiopl recall (Z-1891-2012)Terumo Cardiovascular Systems Corporation2012-06-27
CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardiopleg recall (Z-1892-2012)Terumo Cardiovascular Systems Corporation2012-06-27
CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardiopleg recall (Z-1893-2012)Terumo Cardiovascular Systems Corporation2012-06-27
CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia recall (Z-1894-2012)Terumo Cardiovascular Systems Corporation2012-06-27