DeviceClearance

Impulse Angiographic Catheter, Expo Angiographic Catheter— 510(k) K152605

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K152605 for Impulse Angiographic Catheter, Expo Angiographic Catheter, Substantially Equivalent on 2015-10-29. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant
Boston Scientific Corporation
Product code
Code DQO
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Maple Grove, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQO

product code DQO
Death
35
Injury
993
Malfunction
1,772
Other
5
Total
2,805

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 K152605

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 K152605.

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