DeviceClearance

Direxion and Direxion HI-FLO Torqueable Microcatheters— 510(k) K163701

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K163701 for Direxion and Direxion HI-FLO Torqueable Microcatheters, Substantially Equivalent on 2017-05-16. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant
Boston Scientific Corporation
Product code
Product code KRA
Device class
Class 2
Regulation
21 CFR 870.1210
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Maple Grove, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KRA

view all

More clearances from Boston Scientific Corporation

view all

Adverse events under product code KRA

product code KRA
Death
234
Injury
1,029
Malfunction
3,012
Other
2
Total
4,277

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

Recalls naming K163701

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163701.

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