Intermed, Ins Sterile Water/Saline
FDA 510(k) K842166 · Intermed, Inc.
510(k) numberK842166
Submission
- Device name
- Intermed, Ins Sterile Water/Saline
- Applicant
- Intermed, Inc.
Sparta, NJ, US - Received
- May 31, 1984
- Decision date
- February 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K900857 | Non Sterile Parenteral Supply KitFMF · Traditional | 05/22/1990SEKD |
| K833126 | Dressing Change Trays · Traditional | 01/27/1984SE |
| K833574 | Percutaneous Sheath Introducer TraysDQX · Traditional | 01/11/1984SE |
| K833573 | Central Vein Cath. Tray CC-20-1420DQY · Traditional | 01/11/1984SE |
| K833139 | Acute Hemodialysis TraysKNZ · Traditional | 12/22/1983SE |
| K833059 | Suction Catheter TraysGBZ · Traditional | 12/12/1983SE |
| K821269 | Tracheostomy Care TraysEQN · Traditional | 05/27/1982SE |
| K791427 | Catheterization Trays Foley and UrethralKOD · Traditional | 09/07/1979SE |
| K791426 | Peritoneal PacKDJ · Traditional | 08/28/1979SE |
| K781748 | Irrigation TrayEYN · Traditional | 12/12/1978SE |
Questions and answers
When was Intermed, Ins Sterile Water/Saline cleared by the FDA?
Intermed, Ins Sterile Water/Saline (K842166) received a 510(k) decision of Substantially Equivalent on February 12, 1985, 257 days after the submission was received.
What is the product code of K842166?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.