Atlas FDA

MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER

FDA 510(k) clearance K010016 · decided 2001-10-09

Clearance details

K-number
K010016
Device name
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
Applicant
Cook, Inc.
Decision
Substantially Equivalent
Date received
2001-01-02
Decision date
2001-10-09
Days to decision
280 days
Clearance type
Traditional
Product code
BWC
Device class
2
Regulation number
868.5090
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Bloomington, IN, 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
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RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (K130405)Teleflex Medical2013-11-06
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (K050166)Smiths Medical2005-05-26
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (K013241)Cook, Inc.2002-02-21
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (K013252)Cook, Inc.2002-02-21
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (K013916)Cook, Inc.2001-12-20
KEY CHAIN EMERGENCY AIRWAY (K962312)Ffrench Pocket Emergency Airway, Inc.1997-06-17
ABELSON CRICOTHYROTOMY CANNULA (K952401)Gilbert Surgical Instruments, Inc.1995-07-11
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE (K853345)31st. Centruy Medical Corp.1985-10-01
WEISS EMERGENCY AIRWAY SYSTEM (K790650)Intl. Medical Devices , Ltd.1979-06-27

Recalls involving this device

RecordFirmDate
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCC recall (Z-1785-2026)Cook Incorporated2026-04-06

PMA approvals by this applicant

RecordFirmDate
Zenith® Iliac Branch (P020018/S064)Cook, Inc.2025-05-30
ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065)Cook, Inc.2025-04-09
Zenith Fenestrated AAA Endovascular Graft (P020018/S063)Cook, Inc.2024-04-29
Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061)Cook, Inc.2023-12-14
Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062)Cook, Inc.2023-12-13
Zenith Fenestrated AAA Endovascular Graft (P020018/S060)Cook, Inc.2022-01-20
Zenith AAA Endovascular Graft (P020018/S059)Cook, Inc.2020-10-08
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055)Cook, Inc.2018-10-10