Pediatric Bubble Trap Cat. No. B-100
FDA 510(k) K873610 · American Omni Medical, Inc.
510(k) numberK873610
Submission
- Device name
- Pediatric Bubble Trap Cat. No. B-100
- Applicant
- American Omni Medical, Inc.
Costa Mesa, CA, US - Received
- September 8, 1987
- Decision date
- November 5, 1987
- 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
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| 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 |
|---|---|---|
| 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 |
| K873488 | Silent Guard Cat. No. SG-10DTL · Traditional | 10/07/1987SE |
| K871632 | Nasogastric VoicetubeBTR · Traditional | 09/16/1987SE |
Questions and answers
When was Pediatric Bubble Trap Cat. No. B-100 cleared by the FDA?
Pediatric Bubble Trap Cat. No. B-100 (K873610) received a 510(k) decision of Substantially Equivalent on November 5, 1987, 58 days after the submission was received.
What is the product code of K873610?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.