Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart G — Miscellaneous](/submissions/AN/subpart-g%E2%80%94miscellaneous) → [21 CFR 868.6810](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6810) → BSY — Catheters, Suction, Tracheobronchial # BSY · Catheters, Suction, Tracheobronchial _Anesthesiology · 21 CFR 868.6810 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY ## Overview - **Product Code:** BSY - **Device Name:** Catheters, Suction, Tracheobronchial - **Regulation:** [21 CFR 868.6810](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6810) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway. ## Classification Rationale Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9. ## Recent Cleared Devices (20 of 116) Showing 20 most recent of 116 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K031997](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K031997.md) | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | Mallinckrodt Dar S.R.L. | Nov 25, 2003 | SESE | | [K992902](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K992902.md) | AMBU HAND POWER SUCTION PUMP | Ambu, Inc. | Oct 25, 1999 | SESE | | [K982945](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K982945.md) | DUAL PURPOSE CLOSED CATHETER | Spirit Medical Systems, Inc. | Sep 22, 1998 | SESE | | [K981910](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K981910.md) | SUCTION CATHETER | Ni-Med, Inc. | Aug 24, 1998 | SESE | | [K972258](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K972258.md) | HI-CARE CLOSED SUCTION SYSTEM | Mallinckrodt Medical | Dec 29, 1997 | SESE | | [K973199](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K973199.md) | AMSINO SUCTION CATHETER | Amsino Intl., Inc. | Sep 10, 1997 | SESE | | [K961707](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K961707.md) | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM | Sorenson Critical Care | Mar 11, 1997 | SESE | | [K964369](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K964369.md) | TRACH CARE SET WITH MICROBAN | Ballard Medical Products | Feb 11, 1997 | SESE | | [K960488](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K960488.md) | NEO 2 LINE SUCTION SYSTEM | Alcove Medical, Inc. | Apr 26, 1996 | SESE | | [K955831](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K955831.md) | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | Mar 28, 1996 | SESE | | [K955645](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K955645.md) | CATH-GUIDE | Hudson Respiratory Care, Inc. | Mar 12, 1996 | SESE | | [K952396](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K952396.md) | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | Aug 15, 1995 | SESE | | [K952395](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K952395.md) | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | Aug 15, 1995 | SESE | | [K953226](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K953226.md) | PULM O2 SUCTION CATHETER TRAYS | Premium Plastics, Inc. | Aug 8, 1995 | SESE | | [K951506](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K951506.md) | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Trinity Laboratories, Inc. | Jul 3, 1995 | SESE | | [K945994](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K945994.md) | DUAL PURPOSE CATHETER | Universal Medical Products, Inc. | Jun 21, 1995 | SESE | | [K951745](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K951745.md) | CONNECTING TUBE | Vital Signs, Inc. | May 30, 1995 | SESE | | [K945950](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K945950.md) | TRIGUARD(TM) SUCTION SYSTEM | Vital Signs, Inc. | Dec 27, 1994 | SESE | | [K944251](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K944251.md) | KENDALL MODU-VAC CLOSED SUCTION SYSTEM | Kendall Healthcare Products Co. Div.Of Tyco Health | Sep 21, 1994 | SESE | | [K935600](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY/K935600.md) | TRACHEAL SUCTION CATHETER | Puritas Health Care, Inc. | May 10, 1994 | SESK | ## Top Applicants - Sherwood Medical Co. — 7 clearances - Ballard Medical Products — 5 clearances - Ackrad Laboratories — 4 clearances - American Pharmaseal Div. Ahsc — 4 clearances - Concord Laboratories, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BSY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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