FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATHETER, TRANSLUMINAL BALLOON
K Number: K781772
·
Decision Mar 6, 1979
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
4
Applicant Total
36
Review Days
141
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Basic Information
- Device Name
- CATHETER, TRANSLUMINAL BALLOON
- K Number
- K781772
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medi-Tech, Inc.
- Date Received
- October 16, 1978
- Decision Date
- March 6, 1979
- Product Code
- GBA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBA | Catheter, Balloon Type | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBA), ordered by most recent decision date.
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ELECATH MULTI-PURPOSE ARTERIAL SURGER
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TUBE, LEATHERMAN/IMBRUCE
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FDA Class 1
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Other Clearances by Medi-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | May 15, 1996 | Substantially Equivalent |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | Aug 17, 1995 | Substantially Equivalent |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | Jun 1, 1995 | Substantially Equivalent |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | Dec 13, 1994 | Substantially Equivalent |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | Oct 6, 1994 | Substantially Equivalent |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | Sep 14, 1994 | Substantially Equivalent |
| K922990 | HEMODIALYSIS BATH | Sep 12, 1994 | Substantially Equivalent |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | Sep 9, 1994 | Substantially Equivalent |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Oct 22, 1990 | Substantially Equivalent |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | Nov 2, 1989 | Substantially Equivalent for Some Indications |