Atlas FDA

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k) clearance K142673 · decided 2014-11-18

Clearance details

K-number
K142673
Device name
Bio-Medicus Adult Cannulae and Introducer
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2014-09-19
Decision date
2014-11-18
Days to decision
60 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SynchroMed™ Infusion System; Ascenda™ Intrathecal Catheters (P860004/S459)Medtronic, Inc.2026-08-08
Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ (P960009/S540)Medtronic, Inc.2026-08-08
Sphere-9 Catheter AFR-00001 (P240013/S030)Medtronic, Inc.2026-08-06
Sphere-9 Catheter and Affera Ablation System (P240013/S029)Medtronic, Inc.2026-08-04
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar (P010015/S589)Medtronic, Inc.2026-07-31
Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED (P980035/S846)Medtronic, Inc.2026-07-31
Aurora EV ICD (DVEA3E4) (P220012/S074)Medtronic, Inc.2026-07-31
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S229)Medtronic, Inc.2026-07-31