Atlas FDA

MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER

FDA 510(k) clearance K901603 · decided 1990-05-04

Clearance details

K-number
K901603
Device name
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
Applicant
Bivona Medical Technologies
Decision
Substantially Equivalent
Date received
1990-03-27
Decision date
1990-05-04
Days to decision
38 days
Clearance type
Traditional
Product code
KOB
Device class
2
Regulation number
876.5090
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Gary, IN, US
Third-party review
No
Expedited review
No

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LOWSLEY SUPRAPUBIC TRACTOR (K012153)Circon Video2001-09-19
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RUSCH SUPRAPUBIC TRAY (K970021)Rusch, Inc.1997-02-07
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (K945480)Harry A. Schlakman1995-08-28
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Recalls involving this device

No recalls on record reference this clearance.