4 Sure TM Suction Catheters & Kits

FDA 510(k) K921851 · Boston Pacific Medical, Inc.

Unknown

510(k) numberK921851

Submission

Device name
4 Sure TM Suction Catheters & Kits
Applicant
Boston Pacific Medical, Inc.
Boston, MA, US
Received
April 17, 1992
Decision date
July 7, 1993
Decision
Unknown (SESK)
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
K9331094SURE Uro-Link Urological Procedure TraysKOD · Traditional 03/28/1994SEKD
K9224024 Sure TM Enteral Feeding BagFPD · Traditional 03/25/1994SE
K9310484-SURE Nelaton CatheterEZD · Traditional 02/14/1994SE
K9310474-SURE Female CatheterEZD · Traditional 02/14/1994SE
K9218524 Sure TM Rectal TubeKMO · Traditional 10/08/1993SE
K9218534 Sure TM Feeding TubesKNT · Traditional 07/13/1993SE
K9223984 Sure TM Enema Bag SetFCE · Traditional 06/17/1993SEKD
K9223974 Sure TM Nasal Oxygen CannulaCAT · Traditional 03/18/1993SE
K9249954 Sure TM Anesthesia Extension SetBSO · Traditional 12/30/1992SE
K9224014 Sure TM Colostomy PouchEZQ · Traditional 06/10/1992SE

Questions and answers

When was 4 Sure TM Suction Catheters & Kits cleared by the FDA?

4 Sure TM Suction Catheters & Kits (K921851) received a 510(k) decision of Unknown on July 7, 1993, 446 days after the submission was received.

What is the product code of K921851?

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