Submission Details
| 510(k) Number | K972258 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1997 |
| Decision Date | December 29, 1997 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Traditional
HI-CARE CLOSED SUCTION SYSTEM
Dec 1997
Decision
195d
Days
Class 1
Risk
About This 510(k) Submission
K972258 is an FDA 510(k) clearance for the HI-CARE CLOSED SUCTION SYSTEM, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on December 29, 1997, 195 days after receiving the submission on June 17, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.
Device Classification
| Product Code | BSY — Catheters, Suction, Tracheobronchial |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.6810 |
Manufacturer
Similar Devices — BSY Catheters, Suction, Tracheobronchial
All 115
K031997 · Mallinckrodt Dar S.R.L.
· Nov 2003
K992902 · Ambu, Inc.
· Oct 1999
K982945 · Spirit Medical Systems, Inc.
· Sep 1998
K981910 · Ni-Med, Inc.
· Aug 1998
K973199 · Amsino Intl., Inc.
· Sep 1997
K961707 · Sorenson Critical Care
· Mar 1997
More from Mallinckrodt Medical
View all
K082520
· BTR · Oct 2008
K051416
· JOH · Jun 2005
K971267
· JOH · Sep 1997
K963732
· JOH · Jun 1997
K955721
· CAE · Mar 1997