Hi-Care Closed Suction System
FDA 510(k) K972258 · Mallinckrodt Medical
510(k) numberK972258
Submission
- Device name
- Hi-Care Closed Suction System
- Applicant
- Mallinckrodt Medical
St Louis, MO, US - Received
- June 17, 1997
- Decision date
- December 29, 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 |
| K973199 | Amsino Suction CatheterBSY · Traditional | Amsino Intl., Inc. | 09/10/1997SE |
| K961707 | Trach-Eze Closed Ventilation Suction SystemBSY · Traditional | Sorenson Critical Care | 03/11/1997SE |
| 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 |
More from Hudson Respiratory Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082520 | Sealguard Evac Endotracheal and Endotracheal TubesBTR · Special | 10/02/2008SE |
| K051416 | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaJOH · Special | 06/16/2005SE |
| K971267 | Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…JOH · Traditional | 09/25/1997SE |
| K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…JOH · Traditional | 06/26/1997SE |
| K955721 | Cuffed Oropharyngeal Airway (Copa)CAE · Traditional | 03/28/1997SE |
| K965132 | Hi-Lo Evac and Evac II Endotracheal TubesBTR · Traditional | 03/20/1997SE |
| K962045 | Anesthesia Breathing Circuit/Anesthesia Breathing KitCAH · Traditional | 11/26/1996SE |
| K962173 | Shikey Tracheostomy Tubes and AccessoriesJOH · Traditional | 10/04/1996SE |
| K955680 | Shiley Cuffed Pediatric Tracheostomy Tube; Long CuffedJOH · Traditional | 03/13/1996SE |
| K954749 | Mallinckrodt Shiley 15MM CapJOH · Traditional | 01/24/1996SE |
Questions and answers
When was Hi-Care Closed Suction System cleared by the FDA?
Hi-Care Closed Suction System (K972258) received a 510(k) decision of Substantially Equivalent on December 29, 1997, 195 days after the submission was received.
What is the product code of K972258?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.