FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATH-TECH CHOLANGIOGRAPHY CATHETER
K Number: K842147
·
Decision Oct 2, 1984
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
13
Review Days
125
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Basic Information
- Device Name
- CATH-TECH CHOLANGIOGRAPHY CATHETER
- K Number
- K842147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Catheter Technology Corp.
- Date Received
- May 30, 1984
- Decision Date
- October 2, 1984
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGE), ordered by most recent decision date.
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BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
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FDA Class 2
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Other Clearances by Catheter Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880571 | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | Mar 4, 1988 | Substantially Equivalent |
| K871080 | PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | Aug 12, 1987 | Substantially Equivalent |
| K871998 | GROSHONG CV CATHETER REPAIR KIT | Jun 24, 1987 | Substantially Equivalent |
| K860256 | BRAWN AND GROSHONG CATHETERS | Mar 28, 1986 | Substantially Equivalent |
| K842577 | CATH-TECH POLYURETHANE UMBILICAL VESS | Mar 13, 1985 | Substantially Equivalent |
| K840339 | UMBILICAL VESSEL CATHETER | Jul 25, 1984 | Substantially Equivalent |
| K831386 | GROSHONG CATHETER, LONG TERM TYPE | Oct 14, 1983 | Substantially Equivalent |
| K831366 | TESTCORP PREG | Jun 2, 1983 | Substantially Equivalent |
| K831365 | TESTCORP ANA | Jun 2, 1983 | Substantially Equivalent |
| K831361 | BETA-PREG | Jun 2, 1983 | Substantially Equivalent |