FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAUT BALLOON CATHETER, MODEL 50640
K Number: K011018
·
Decision Jun 22, 2001
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
16
Review Days
79
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Basic Information
- Device Name
- TAUT BALLOON CATHETER, MODEL 50640
- K Number
- K011018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Taut, Inc.
- Date Received
- April 4, 2001
- Decision Date
- June 22, 2001
- Product Code
- GCA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCA), ordered by most recent decision date.
Disposable Stone Retrieval Balloon Catheter
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Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
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SpyGlass Discover Balloon Dilation Catheter
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Other Clearances by Taut, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023261 | ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 | Dec 13, 2002 | Substantially Equivalent |
| K021731 | ADAPT OPEN ACCESS PORT, MODEL 41233 | Aug 8, 2002 | Substantially Equivalent |
| K003703 | TAUT-INSUFFLATION NEEDLE | Feb 22, 2001 | Substantially Equivalent |
| K010007 | ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP | Feb 22, 2001 | Substantially Equivalent |
| K992904 | MINI-PORT | Oct 5, 1999 | Substantially Equivalent |
| K992907 | INTRADUCER | Oct 5, 1999 | Substantially Equivalent |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | Dec 1, 1997 | Substantially Equivalent |
| K962003 | TUAT SPLATTER CONTROL SHIELD SCS-300 | Jul 18, 1996 | Substantially Equivalent |
| K960883 | INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 | Mar 20, 1996 | Substantially Equivalent |
| K945486 | SPLATTER CONTROL SHIELD | Feb 28, 1995 | Substantially Equivalent |