Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4290](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4290) → DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass # DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4290 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL ## Overview - **Product Code:** DTL - **Device Name:** Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4290](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4290) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Recent Cleared Devices (20 of 137) Showing 20 most recent of 137 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K152528](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K152528.md) | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | Dec 2, 2015 | SESE | | [K143429](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K143429.md) | Passage Hemostasis Valve | Merit Medical Systems, Inc. | Dec 22, 2014 | SESE | | [K140475](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K140475.md) | ROTATING ADAPTERS | Merit Medical Systems, Inc. | Apr 16, 2014 | SESE | | [K131124](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K131124.md) | COLIGN | Jilin Coronado Medical , Ltd. | Aug 28, 2013 | SESE | | [K123448](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K123448.md) | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE | Medtronic, Inc. | Dec 13, 2012 | SESE | | [K122811](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K122811.md) | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE | Medtronic, Inc. | Oct 12, 2012 | SESE | | [K122301](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K122301.md) | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | Vascular Solutions Zerusa , Ltd. | Sep 7, 2012 | SESE | | [K120069](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K120069.md) | MEDLINE STOPCOCK AND MANIFOLD | Medline Industries, Inc. | Apr 3, 2012 | SESE | | [K113148](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K113148.md) | E-PASS | Synexmed(Shenzhen)Company Limited | Feb 28, 2012 | SESE | | [K113845](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K113845.md) | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE | Medtronic, Inc. | Jan 25, 2012 | SESE | | [K113132](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K113132.md) | DISPOSABLE HEMOSTATIC Y-CONNECTORS | Coeur, Inc. | Jan 20, 2012 | SESE | | [K113667](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K113667.md) | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING | Edwards Lifesciences, LLC | Jan 12, 2012 | SESE | | [K101113](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K101113.md) | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | May 21, 2010 | SESE | | [K093992](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K093992.md) | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | May 19, 2010 | SESE | | [K100319](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K100319.md) | MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L | Merit Medical Systems, Inc. | Apr 28, 2010 | SESE | | [K091634](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K091634.md) | NMI FC | Navilyst Medical, Inc. | Mar 1, 2010 | SESE | | [K092563](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K092563.md) | GATOR CLIPSEAL PLUG | Vascular Solutions, Inc. | Nov 4, 2009 | SESE | | [K092711](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K092711.md) | GUARDIAN II HEMOSTASIS VALVE | Zerusa Limited | Oct 1, 2009 | SESE | | [K080472](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K080472.md) | SEDAT MYSHELL LITE | Sedat | Apr 23, 2008 | SESE | | [K073260](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K073260.md) | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 | Device Partners International | Mar 13, 2008 | SESE | ## Top Applicants - Merit Medical Systems, Inc. — 9 clearances - Texas Medical Products, Inc. — 5 clearances - North American Instrument Corp. — 5 clearances - Dlp, Inc. — 5 clearances - Zerusa Limited — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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