Atlas FDA

CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY

FDA 510(k) clearance K133597 · decided 2014-04-18

Clearance details

K-number
K133597
Device name
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
Applicant
Cook, Inc.
Decision
Substantially Equivalent
Date received
2013-11-22
Decision date
2014-04-18
Days to decision
147 days
Clearance type
Traditional
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Bloomington, IN, US
Third-party review
No
Expedited review
No

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

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Recalls involving this device

RecordFirmDate
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part N recall (Z-1781-2026)Cook Incorporated2026-04-06

PMA approvals by this applicant

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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