Silent Guard Cat. No. SG-10
FDA 510(k) K873488 · American Omni Medical, Inc.
510(k) numberK873488
Submission
- Device name
- Silent Guard Cat. No. SG-10
- Applicant
- American Omni Medical, Inc.
Costa Mesa, CA, US - Received
- August 31, 1987
- Decision date
- October 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4290
- Specialty
- Cardiovascular
Other 510(k)s with product code DTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152528 | Attachable Cath Lab Hemostasis ValveDTL · Traditional | Galt Medical Corp. | 12/02/2015SE |
| K143429 | Passage Hemostasis ValveDTL · Special | Merit Medical Systems, Inc. | 12/22/2014SE |
| K140475 | Rotating AdaptersDTL · Traditional | Merit Medical Systems, Inc. | 04/16/2014SE |
| K131124 | ColignDTL · Traditional | Jilin Coronado Medical , Ltd. | 08/28/2013SE |
| K123448 | Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…DTL · Special | Medtronic, Inc. | 12/13/2012SE |
| K122811 | Connector Components with Balance BiosurfaceDTL · Special | Medtronic, Inc. | 10/12/2012SE |
| K122301 | Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveDTL · Traditional | Vascular Solutions Zerusa , Ltd. | 09/07/2012SE |
| K120069 | Medline Stopcock and ManifoldDTL · Traditional | Medline Industries, Inc. | 04/03/2012SE |
| K113148 | E-PassDTL · Traditional | Synexmed(Shenzhen)Company Limited | 02/28/2012SE |
| K113845 | Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceDTL · Special | Medtronic, Inc. | 01/25/2012SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922781 | Flow Conrol ValveMJJ · Traditional | 03/08/1993SE |
| K922356 | Flow Control Valve, Cat. No. ACV-38MJJ · Traditional | 02/12/1993SE |
| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | 04/03/1990SE |
| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | 01/30/1989SE |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | 01/24/1989SE |
| K873316 | Bubble Trap-Filter Cat. No B180F37DTM · Traditional | 07/14/1988SE |
| K875080 | Air Vent Line Cat. No. AVL-36DTM · Traditional | 02/29/1988SE |
| K873802 | Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional | 11/06/1987SE |
| K873610 | Pediatric Bubble Trap Cat. No. B-100BSY · Traditional | 11/05/1987SE |
| K871632 | Nasogastric VoicetubeBTR · Traditional | 09/16/1987SE |
Questions and answers
When was Silent Guard Cat. No. SG-10 cleared by the FDA?
Silent Guard Cat. No. SG-10 (K873488) received a 510(k) decision of Substantially Equivalent on October 7, 1987, 37 days after the submission was received.
What is the product code of K873488?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.