FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
K Number: K873455
·
Decision Sep 14, 1987
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
16
Review Days
17
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Basic Information
- Device Name
- S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
- K Number
- K873455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dravon Medical, Inc.
- Date Received
- August 28, 1987
- Decision Date
- September 14, 1987
- Product Code
- FJK
- 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 |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Dravon Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860770 | AM-100 I/A AMPAC | Apr 21, 1986 | Substantially Equivalent |
| K832739 | STEDIFLO INFUSION SET | Dec 22, 1983 | Substantially Equivalent |
| K831842 | DRAVON T CLAMP | Sep 26, 1983 | Substantially Equivalent |
| K812771 | PERITONEAL DIALYSIS DRAINAGE | Oct 19, 1981 | Substantially Equivalent |
| K812772 | PERITONEAL DIALYSIS CYCLER SET (8UNIT) | Oct 19, 1981 | Substantially Equivalent |
| K811851 | S-610 SHUNT ADAPTOR SET | Aug 31, 1981 | Substantially Equivalent |
| K800435 | HEMOSTATIC/TUBE OCCLUDING FORCEPS | Mar 12, 1980 | Substantially Equivalent |
| K782057 | CATHETER, RADIOPAQUE TENCKHOFF | Feb 27, 1979 | Substantially Equivalent |
| K782058 | CATHETER, BETA-CAP-PERITONEAL | Feb 27, 1979 | Substantially Equivalent |
| K781755 | DAP-PAK | Feb 15, 1979 | Substantially Equivalent |