FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GROSHONG CV CATHETER REPAIR KIT
K Number: K871998
·
Decision Jun 24, 1987
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
13
Review Days
29
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Basic Information
- Device Name
- GROSHONG CV CATHETER REPAIR KIT
- K Number
- K871998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Catheter Technology Corp.
- Date Received
- May 26, 1987
- Decision Date
- June 24, 1987
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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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 |
| K860256 | BRAWN AND GROSHONG CATHETERS | Mar 28, 1986 | Substantially Equivalent |
| K842577 | CATH-TECH POLYURETHANE UMBILICAL VESS | Mar 13, 1985 | Substantially Equivalent |
| K842147 | CATH-TECH CHOLANGIOGRAPHY CATHETER | Oct 2, 1984 | 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 |