Intersept Filtered Cardiotomy Reservoir— 510(k) K151110

Name: FDA 510(k) clearance K151110
Creator: U.S. Food and Drug Administration
Published: 2015-05-27

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K151110 for Intersept Filtered Cardiotomy Reservoir, Substantially Equivalent on 2015-05-27. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 2015-04-27
Decision date: 2015-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTN

view all

K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
K241206 — Quantum Perfusion Hybrid System2024-07-18
K241053 — MVR Venous Reservoir Bag 800 mL +3 more2024-05-15
K223361 — BMR 1900 PHISIO2023-06-10
K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface2017-03-17

More clearances from Medtronic, Inc.

view all

K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)2026-08-28
K262005 — Affera Integrated Mapping System2026-08-21
K261335 — VitalFlow Set with Balance Biosurface2026-07-31
K261866 — Concerto Versa Detachable Coil2026-06-24
K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.