Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
FDA 510(k) K170583 · Medtronic, Inc.
510(k) numberK170583
Submission
- Device name
- Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
- Applicant
- Medtronic, Inc.
Minneapolis, MN, US - Received
- February 28, 2017
- Decision date
- March 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
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| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous…DTN · Special | Medtronic Cardiac Surgery | 05/15/2024SE |
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| K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F CDTN · Traditional | Sorin Group Italia S.R.L. | 03/08/2017SE |
| K153143 | Capiox Advance Hardshell ReservoirDTN · Special | Terumo Cardiovascular Systems Corporation | 12/02/2015SE |
| K151110 | Intersept Filtered Cardiotomy ReservoirDTN · Special | Medtronic, Inc. | 05/27/2015SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | Maquet Cardiopulmonary, AG | 07/07/2014SE |
| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
| K140321 | Initary Better Bladder-PediatricDTN · Special | Circulatory Technology, Inc. | 04/17/2014SE |
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| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | 02/19/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | 01/20/2026SE |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | 01/16/2026SE |
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Questions and answers
When was Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface cleared by the FDA?
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (K170583) received a 510(k) decision of Substantially Equivalent on March 17, 2017, 17 days after the submission was received.
What is the product code of K170583?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.