Paragon Adult Maxi PMP Oxygenator with Tubing Pack

FDA 510(k) K201642 · Chalice Medical , Ltd.

Substantially Equivalent

510(k) numberK201642

Submission

Device name
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Applicant
Chalice Medical , Ltd.
Worksop, GB
Received
June 17, 2020
Decision date
September 18, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTZ – Oxygenator, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4350
Specialty
Cardiovascular
Life-sustaining
Yes

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K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special Medtronic, Inc.06/12/2024SE
K231652D100 Kids; D101 KidsDTZ · Special Sorin Group Italia S.R.L.11/16/2023SE
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More from Chalice Medical , Ltd.

510(k)DeviceDecision
K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional 11/01/2023SE
K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)DTZ · Traditional 02/28/2020SE

Questions and answers

When was Paragon Adult Maxi PMP Oxygenator with Tubing Pack cleared by the FDA?

Paragon Adult Maxi PMP Oxygenator with Tubing Pack (K201642) received a 510(k) decision of Substantially Equivalent on September 18, 2020, 93 days after the submission was received.

What is the product code of K201642?

The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.