Components for Cardiovascular Procedure Kit - Heat Exchanger Coils

FDA 510(k) K000977 · Olson Medical Sales, Inc.

Substantially Equivalent

510(k) numberK000977

Submission

Device name
Components for Cardiovascular Procedure Kit - Heat Exchanger Coils
Applicant
Olson Medical Sales, Inc.
Elkton, MD, US
Received
March 27, 2000
Decision date
March 23, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTR – Heat-Exchanger, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4240
Specialty
Cardiovascular
Life-sustaining
Yes

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K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special Sorin Group Italia S.R.L.05/30/2025SE
K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special Medtronic02/23/2024SE
K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special Quara S.R.L.04/13/2023SE
K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional Qura S.R.L05/06/2022SE
K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional Qura S.R.L01/10/2022SE
K201984MPS 3 ND Myocardial Protection SystemDTR · Traditional Quest Medical, Inc.11/20/2020SE
K200438MPS 3 Myocardial Protection SystemDTR · Traditional Quest Medical, Inc.06/19/2020SE
K173716MPS2 Myocardial Protection System ConsoleDTR · Traditional Quest Medical, Inc.10/01/2018SE

More from Quest Medical, Inc.

510(k)DeviceDecision
K993060Gas FilterJOD · Traditional 03/28/2000SE
K993062Chest Drainage TubingDWE · Traditional 12/10/1999SE
K992906Components for Cardiovascular Procedure KitDTL · Traditional 11/10/1999SE

Questions and answers

When was Components for Cardiovascular Procedure Kit - Heat Exchanger Coils cleared by the FDA?

Components for Cardiovascular Procedure Kit - Heat Exchanger Coils (K000977) received a 510(k) decision of Substantially Equivalent on March 23, 2001, 361 days after the submission was received.

What is the product code of K000977?

The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.