Trach-Eze Closed Ventilation Suction System
FDA 510(k) K961707 · Sorenson Critical Care
510(k) numberK961707
Submission
- Device name
- Trach-Eze Closed Ventilation Suction System
- Applicant
- Sorenson Critical Care
Salt Lake City, UT, US - Received
- May 2, 1996
- Decision date
- March 11, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSY – Catheters, Suction, Tracheobronchial
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6810
- Specialty
- Anesthesiology
Other 510(k)s with product code BSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031997 | Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction SystemBSY · Traditional | Mallinckrodt Dar S.R.L. | 11/25/2003SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | Ambu, Inc. | 10/25/1999SE |
| K982945 | Dual Purpose Closed CatheterBSY · Traditional | Spirit Medical Systems, Inc. | 09/22/1998SE |
| K981910 | Suction CatheterBSY · Traditional | Ni-Med, Inc. | 08/24/1998SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | Mallinckrodt Medical | 12/29/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | Amsino Intl., Inc. | 09/10/1997SE |
| K964369 | Trach Care Set with MicrobanBSY · Traditional | Ballard Medical Products | 02/11/1997SE |
| K960488 | Neo 2 Line Suction SystemBSY · Traditional | Alcove Medical, Inc. | 04/26/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | Sherwood Medical Co. | 03/28/1996SE |
| K955645 | Cath-GuideBSY · Traditional | Hudson Respiratory Care, Inc. | 03/12/1996SE |
Questions and answers
When was Trach-Eze Closed Ventilation Suction System cleared by the FDA?
Trach-Eze Closed Ventilation Suction System (K961707) received a 510(k) decision of Substantially Equivalent on March 11, 1997, 313 days after the submission was received.
What is the product code of K961707?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.