Suction Catheter Kit, Sterile, Single-Use
FDA 510(k) K951506 · Trinity Laboratories, Inc.
510(k) numberK951506
Submission
- Device name
- Suction Catheter Kit, Sterile, Single-Use
- Applicant
- Trinity Laboratories, Inc.
Salisbury, MD, US - Received
- April 3, 1995
- Decision date
- July 3, 1995
- 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 |
| 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 |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K981441 | Heart Cath Tray, Sterile, DisposableDQO · Traditional | 07/10/1998SE |
| K974238 | Dental Tray, Sterile, DisposableEIA · Traditional | 02/04/1998SE |
| K974286 | Circumcision Tray, Cat. No. 70340HFX · Traditional | 12/12/1997SE |
| K972160 | Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex…DCK · Traditional | 08/01/1997SE |
| K970722 | Eye TrayKKX · Traditional | 03/31/1997SE |
| K965201 | O.R. Scrub Prep Tray, Sterile, DisposableLRO · Traditional | 02/14/1997SEKD |
| K964921 | Basic Biopsy Tray. Disposable, SterileLRO · Traditional | 01/22/1997SE |
| K953929 | Mid-Stream Collection Set-SterileLIO · Traditional | 11/16/1995SE |
| K952058 | Sterile V.A.D. (Vascular Access Devices) Access Kit, DisposableFOZ · Traditional | 09/21/1995SE |
| K953070 | Woundfoam 4 X 4KMF · Traditional | 09/08/1995SE |
Questions and answers
When was Suction Catheter Kit, Sterile, Single-Use cleared by the FDA?
Suction Catheter Kit, Sterile, Single-Use (K951506) received a 510(k) decision of Substantially Equivalent on July 3, 1995, 91 days after the submission was received.
What is the product code of K951506?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.