DeviceClearance

IMAGER II ANGIOGRAPHIC CATHETER— 510(k) K121694

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K121694 for IMAGER II ANGIOGRAPHIC CATHETER, Substantially Equivalent on 2012-09-14. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant
Boston Scientific Corp
Product code
Product code DQO
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
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 K121694

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 K121694.

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