Mechanical Guidewire— 510(k) K221351

Name: FDA 510(k) clearance K221351
Creator: U.S. Food and Drug Administration
Published: 2022-12-19

Substantially Equivalent

Baylis Medical Company, Inc.

FDA 510(k) clearance K221351 for Mechanical Guidewire, Substantially Equivalent on 2022-12-19. Applicant: Baylis Medical Company, Inc.. Device class: 2.

Clearance details

Applicant: Baylis Medical Company, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2022-05-10
Decision date: 2022-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

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K233647 — VersaCross Connect Transseptal Dilator2023-12-14
K213898 — ProTrack Pigtail Wire2023-03-01

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.