FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K Number: K873771
·
Decision Dec 18, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
22
Same Product Code
12
Applicant Total
31
Review Days
93
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Basic Information
- Device Name
- HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
- K Number
- K873771
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4545
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- American V. Mueller
- Date Received
- September 16, 1987
- Decision Date
- December 18, 1987
- Product Code
- GYK
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GYK | Instrument, Shunt System Implantation | FDA class 1 | Neurology |
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Other Clearances by American V. Mueller
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K850947 | V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS | Apr 17, 1985 | Substantially Equivalent |