FDA 510(k)

SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER

K-Number: K912920 · 1991-09-25

Decision Date1991-09-25

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Ltd.. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K912920. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER?

SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is 3M Health Care, Ltd.. The 510(k) number is K912920.

When did SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER receive FDA 510(k) clearance?

SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER received FDA 510(k) clearance on 1991-09-25, under 510(k) number K912920.

Who is the listed applicant for SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER?

The FDA 510(k) record lists 3M Health Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER?

The FDA product code for SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER is DTZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing 3M Health Care, Ltd. as applicant

K953904SARNS 9000 UNIVERSAL ROLLER PUMP K926364ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X K941534MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM K941748STERI-VAC GAS STERILIZER MODEL 8XL K9306813M PREVENTION FABRIC SURGICAL GOWN #78XX K9323073M MAXI-DRIVER II DBATTERY POWERED SYSTEM

View all 49 devices →

Related Devices (Code: DTZ)

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.L K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.