FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
LEATHER VALVULOTOME
K Number: K821569
·
Decision May 27, 1982
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
31
Review Days
—
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Basic Information
- Device Name
- LEATHER VALVULOTOME
- K Number
- K821569
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- American V. Mueller
- Date Received
- May 27, 1982
- Decision Date
- May 27, 1982
- Product Code
- DWS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
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Other Clearances by American V. Mueller
| K Number | Device Name | ||
|---|---|---|---|
| K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | Dec 18, 1987 | Substantially Equivalent |
| K873332 | MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM | Sep 8, 1987 | Substantially Equivalent |
| K871685 | HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS | Jun 12, 1987 | Substantially Equivalent |
| K864676 | HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM | Dec 29, 1986 | Substantially Equivalent |
| K862772 | V. MUELLER (R) GOOSENECK CIRCULAR STAPLER | Aug 18, 1986 | Substantially Equivalent |
| K861471 | V. MUELLER VITAL CLIP-HEMOSTATIC CLIP | Jun 6, 1986 | Substantially Equivalent |
| K854568 | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | Dec 2, 1985 | Substantially Equivalent |
| K854049 | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT | Nov 27, 1985 | Substantially Equivalent |
| K851082 | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | Jul 22, 1985 | Substantially Equivalent |
| K851974 | V. MUELLER VITAL SKIN STAPLER | Jun 11, 1985 | Substantially Equivalent |