Atlas FDA

Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

FDA 510(k) clearance K251499 · decided 2025-06-11

Clearance details

K-number
K251499
Device name
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
Applicant
William Cook Europe Aps
Decision
Substantially Equivalent
Date received
2025-05-15
Decision date
2025-06-11
Days to decision
27 days
Clearance type
Special
Product code
BTR
Device class
2
Regulation number
868.5730
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Bjaeverskov, DK
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Zenith Dissection Endovascular System (ZDEG/ZDES) (P180001/S018)William Cook Europe Aps2026-08-04
Zenith Fenestrated AAA Endovascular Graft (P180001/S017)William Cook Europe Aps2026-05-21
Zenith Dissection Endovascular System (P180001/S016)William Cook Europe Aps2026-05-08
Zenith Dissection Endovascular System (P180001/S015)William Cook Europe Aps2025-05-19
Zenith Dissection Endovascular System (P180001/S014)William Cook Europe Aps2024-07-19
Zenith Dissection Endovascular System (P180001/S013)William Cook Europe Aps2024-07-09
Zenith Dissection Endovascular System (P180001/S012)William Cook Europe Aps2024-04-29
Zenith® Dissection Endovascular System (P180001/S010)William Cook Europe Aps2023-12-15