Meconium Aspiration

FDA 510(k) K912596 · Pacific Device, Inc.

Substantially Equivalent

510(k) numberK912596

Submission

Device name
Meconium Aspiration
Applicant
Pacific Device, Inc.
San Diego, CA, US
Received
June 10, 1991
Decision date
July 30, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K031997Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction SystemBSY · Traditional Mallinckrodt Dar S.R.L.11/25/2003SE
K992902Ambu Hand Power Suction PumpBSY · Traditional Ambu, Inc.10/25/1999SE
K982945Dual Purpose Closed CatheterBSY · Traditional Spirit Medical Systems, Inc.09/22/1998SE
K981910Suction CatheterBSY · Traditional Ni-Med, Inc.08/24/1998SE
K972258Hi-Care Closed Suction SystemBSY · Traditional Mallinckrodt Medical12/29/1997SE
K973199Amsino Suction CatheterBSY · Traditional Amsino Intl., Inc.09/10/1997SE
K961707Trach-Eze Closed Ventilation Suction SystemBSY · Traditional Sorenson Critical Care03/11/1997SE
K964369Trach Care Set with MicrobanBSY · Traditional Ballard Medical Products02/11/1997SE
K960488Neo 2 Line Suction SystemBSY · Traditional Alcove Medical, Inc.04/26/1996SE
K955831Argyle Aspr-Care Closed Suction SystemBSY · Traditional Sherwood Medical Co.03/28/1996SE

More from Sherwood Medical Co.

510(k)DeviceDecision
K972464Vitalmix Plus Empty I.V. ContainerKPE · Traditional 11/05/1997SE
K923782Transfer SetLHI · Traditional 07/02/1993SE
K912860Intravascular Administration SetsFPA · Traditional 08/28/1991SE
K902482Vitalmix (Set & Bag)LHI · Traditional 07/02/1990SE

Questions and answers

When was Meconium Aspiration cleared by the FDA?

Meconium Aspiration (K912596) received a 510(k) decision of Substantially Equivalent on July 30, 1991, 50 days after the submission was received.

What is the product code of K912596?

The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.