Infection Control Valve
FDA 510(k) K841480 · Superior Plastic Products Corp.
510(k) numberK841480
Submission
- Device name
- Infection Control Valve
- Applicant
- Superior Plastic Products Corp.
Mchenry, IL, US - Received
- April 9, 1984
- Decision date
- April 25, 1984
- 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 |
|---|---|---|
| K851981 | No. 5300-3 1/2 French Umbilical Vessel Cath. Etc.FOZ · Traditional | 06/18/1985SE |
| K843975 | 9 French 42LONG Polyurethane Graduated Enteric FeKNT · Traditional | 11/20/1984SE |
| K841945 | Enteral Feeding BottleKNT · Traditional | 07/26/1984SE |
| K841630 | Enteral Nutrition PumpFRN · Traditional | 06/07/1984SE |
| K840324 | Silicone Sump Drain 20 & 40 FrenchJCY · Traditional | 04/25/1984SE |
| K840323 | Silicone Suction & Irrigation DrainGBX · Traditional | 04/25/1984SE |
| K833687 | Dispos. Enteric Feeding Tubes W/Safe-TKNT · Traditional | 03/02/1984SE |
| K833947 | Superior Enternal Feeding SystemKNT · Traditional | 02/04/1984SE |
| K820460 | 3.5 & 5.5 Oz. Sodium Chloride SolutionJOL · Traditional | 03/08/1982SE |
| K812312 | Sterile Water 4OZ.JOL · Traditional | 11/13/1981SE |
Questions and answers
When was Infection Control Valve cleared by the FDA?
Infection Control Valve (K841480) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 16 days after the submission was received.
What is the product code of K841480?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.