DeviceClearance

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER— 510(k) K083919

Substantially Equivalent

Invatec Innovative Technologies, S.R.L.

FDA 510(k) clearance K083919 for AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER, Substantially Equivalent on 2009-03-13. Applicant: Invatec Innovative Technologies, S.R.L.. Device class: 2.

Clearance details

Applicant
Invatec Innovative Technologies, S.R.L.
Product code
Code DQY
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bethlehem, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQY

product code DQY
Death
464
Injury
4,489
Malfunction
13,721
Other
2
Total
18,676

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 K083919

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 K083919.

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