Meconium Aspirator
FDA 510(k) K871407 · Intertech Resources, Inc.
510(k) numberK871407
Submission
- Device name
- Meconium Aspirator
- Applicant
- Intertech Resources, Inc.
Fort Myers, FL, US - Received
- April 8, 1987
- Decision date
- June 15, 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
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 |
|---|---|---|
| K961318 | 1ST Response Disposable ManometerCAP · Traditional | 12/17/1996SE |
| K955008 | Heat & Moisture ExchangerBYD · Traditional | 01/30/1996SE |
| K953580 | Heat Moisture ExchangerBYD · Traditional | 09/15/1995SE |
| K952223 | Xenon Gas Breathing CircuitIYT · Traditional | 08/11/1995SE |
| K952214 | Sims Intertech Hyperinflation Bag SystemNHK · Traditional | 06/08/1995SE |
| K952169 | Safe Response Mouth-To-Mask Resuscitator, PediatricBTM · Traditional | 06/08/1995SE |
| K952062 | PFT FilterCAH · Traditional | 06/08/1995SE |
| K935036 | Hepa Filtered Heat and Moisture ExchangerBYD · Traditional | 01/25/1994SESK |
| K930816 | Hepa Filtered HmeCAH · Traditional | 07/01/1993SE |
| K922479 | Disposable Anesthesia Breathing Circuit, ModifiedBZO · Traditional | 10/30/1992SE |
Questions and answers
When was Meconium Aspirator cleared by the FDA?
Meconium Aspirator (K871407) received a 510(k) decision of Substantially Equivalent on June 15, 1987, 68 days after the submission was received.
What is the product code of K871407?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.