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510k Database
Manufacturers
US
Bioteque Corp.
Medical Device Manufacturer
·
US , Levittown , PA
Bioteque Corp. - FDA 510(k) Cleared Devices
11 submissions
·
10 cleared
·
Since 1992
11
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bioteque Corp.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 22, 2016
Sheath Introducer
K150932
·
DRE
Cardiovascular
·
473d
Cleared
Sep 09, 2011
BIOTEQ ANGIOGRAPHIC CATHETER
K102633
·
DQO
Cardiovascular
·
361d
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11
Gastroenterology & Urology
5
General Hospital
3
Cardiovascular
2
Obstetrics & Gynecology
1