Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4340](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4340) → DTW — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass # DTW · Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4340 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW ## Overview - **Product Code:** DTW - **Device Name:** Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4340](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4340) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value. ## 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 (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K150530](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K150530.md) | Level Sensor, Level Sensor Tape | Medtronic, Inc. | May 8, 2015 | SESE | | [K041558](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K041558.md) | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Stockert Instrumente GmbH | Jul 2, 2004 | SESE | | [K992857](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K992857.md) | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | Rocky Mountain Research, Inc. | Nov 10, 1999 | SESE | | [K955152](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K955152.md) | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Stoeckert Instrumente | Feb 22, 1996 | SESE | | [K910599](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K910599.md) | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | Jtl Medical Corp. | May 20, 1993 | SESE | | [K924354](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K924354.md) | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | Sorin Biomedica, Fiat, USA, Inc. | Feb 18, 1993 | SESE | | [K915337](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K915337.md) | CAPIOX LEVEL ALARM | Terumo Medical Corp. | Feb 21, 1992 | SESE | | [K900910](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K900910.md) | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | Cobe Laboratories, Inc. | May 22, 1990 | SESE | | [K900815](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K900815.md) | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | 3M Company | May 9, 1990 | SESE | | [K873206](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K873206.md) | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Respiratory Support Products, Inc. | Sep 30, 1987 | SESE | | [K860076](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K860076.md) | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | Gambro, Inc. | May 30, 1986 | SESE | | [K852407](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K852407.md) | SENSOR TAPE CAT. NO. ST-45 | American Omni Medical, Inc. | Oct 21, 1985 | SESE | | [K843802](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K843802.md) | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Shiley, Inc. | Dec 27, 1984 | SESE | | [K831879](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K831879.md) | UNIVERSAL LEVEL SENSOR | 3M Health Care, Sarns | Jul 26, 1983 | SESE | | [K823712](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K823712.md) | BEL BLOOD LEVEL DETECTOR | R. Scott Bell | Feb 7, 1983 | SESE | | [K822821](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K822821.md) | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | Gambro, Inc. | Oct 18, 1982 | SESE | | [K781145](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW/K781145.md) | MONITOR KITS, BLOOD LEVEL | 3M Health Care, Sarns | Jul 27, 1978 | SESE | ## Top Applicants - Gambro, Inc. — 2 clearances - 3M Health Care, Sarns — 2 clearances - Terumo Medical Corp. — 1 clearance - Stoeckert Instrumente — 1 clearance - Stockert Instrumente GmbH — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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