Atlas FDA

OPEN ENDED URETERAL CATHETER

FDA 510(k) clearance K830840 · decided 1983-04-06

Clearance details

K-number
K830840
Device name
OPEN ENDED URETERAL CATHETER
Applicant
Van-Tec, Inc.
Decision
Substantially Equivalent
Date received
1983-03-16
Decision date
1983-04-06
Days to decision
21 days
Clearance type
Traditional
Product code
GBM
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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Jimushi Sterile Urethral Catheter for single use (K200134)Hangzhou Jimushi Meditech Co., Ltd.2020-06-01
LotusCatheter (Lotus No Balloon Catheter) (K191512)Hakki Medical Technologies, Inc.2020-05-21
Actreen Hi-Lite Intermittent Urinary Catheters (K192577)B.Braun Medical, Inc.2020-05-07
VaPro Plus Pocket, VaPro Plus (K193148)Hollister Incorporated2019-12-13
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter (K192468)Hangzhou Bever Medical Devices Co., Ltd.2019-11-27
Infyna Chic (K191633)Hollister Incorporated2019-07-19

Recalls involving this device

RecordFirmDate
Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number: 40 recall (Z-0734-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 40 recall (Z-0735-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 40 recall (Z-0736-03)Boston Scientific Corporation2003-04-17
Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 40 recall (Z-0740-03)Boston Scientific Corporation2003-04-17