Atlas FDA

PERCUTANEOUS TRACHEOSTOMY KIT

FDA 510(k) clearance K936133 · decided 1994-03-23

Clearance details

K-number
K936133
Device name
PERCUTANEOUS TRACHEOSTOMY KIT
Applicant
Smiths Industries Medical Systems, Inc.
Decision
Unknown
Date received
1993-12-23
Decision date
1994-03-23
Days to decision
90 days
Clearance type
Traditional
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Keene, NH, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT (K251313)Covidien, LLC2025-12-29
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Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (K193133)Cook Incorporated2019-12-12
Shiley Neonatal/Pediatric Tracheostomy Tube (K182861)Covidien2019-03-22
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (K173912)Smiths Medical Asd, Inc.2018-05-08
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S005)Smiths Industries Medical Systems, Inc.1993-12-27
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S003)Smiths Industries Medical Systems, Inc.1992-04-21
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S004)Smiths Industries Medical Systems, Inc.1992-04-21
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S002)Smiths Industries Medical Systems, Inc.1992-02-25
TROPHOCAN TM (P890024/S001)Smiths Industries Medical Systems, Inc.1990-08-17
TROPHOCAN TM (P890024)Smiths Industries Medical Systems, Inc.1990-08-09