Atlas FDA

VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER

FDA 510(k) clearance K870694 · decided 1987-03-10

Clearance details

K-number
K870694
Device name
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER
Applicant
Van-Tec, Inc.
Decision
Substantially Equivalent
Date received
1987-02-19
Decision date
1987-03-10
Days to decision
19 days
Clearance type
Traditional
Product code
KOD
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Spencer, IN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm) Product Number: 40 recall (Z-0737-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x 70 cm) Product Number: 40 recall (Z-0738-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (7 Fr x 70 cm) Product Number: 40 recall (Z-0739-03)Boston Scientific Corporation2003-04-17