Cleared Special

K241053 - MVR™ Venous Reservoir Bag 800 mL (FDA 510(k) Clearance)

Also includes:
MVR™ Venous Reservoir Bag 1600 mL MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241053 · Medtronic Cardiac Surgery · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
28d
Days
Class 2
Risk

K241053 is an FDA 510(k) clearance for the MVR™ Venous Reservoir Bag 800 mL. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Medtronic Cardiac Surgery (Mounds View, US). The FDA issued a Cleared decision on May 15, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Cardiac Surgery devices

Submission Details

510(k) Number K241053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2024
Decision Date May 15, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.