FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORAY FILTRYZER DIALYZERS
K Number: K884339
·
Decision Mar 17, 1989
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
130
Applicant Total
18
Review Days
154
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Basic Information
- Device Name
- TORAY FILTRYZER DIALYZERS
- K Number
- K884339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Toray Industries (America), Inc.
- Date Received
- October 14, 1988
- Decision Date
- March 17, 1989
- Product Code
- FJI
- 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 |
|---|---|---|---|
| FJI | Dialyzer, Capillary, Hollow Fiber | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Toray Industries (America), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042370 | TORAYGUIDE GUIDEWIRE | Dec 17, 2004 | Substantially Equivalent |
| K030050 | TORAYSULFONE DIALYZER, BS-L SERIES | Sep 29, 2003 | Substantially Equivalent |
| K002512 | TORAYSULFONE DIALYZER | Oct 15, 2001 | Substantially Equivalent |
| K994198 | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L | Aug 25, 2000 | Substantially Equivalent |
| K942681 | FILTRYZER | Jun 22, 1995 | Substantially Equivalent |
| K935471 | FILTRYZER(TM) | May 19, 1995 | Substantially Equivalent |
| K940910 | FILTRYZER | May 4, 1995 | Substantially Equivalent |
| K883407 | TORAY FILTRYZER BK SERIES | Feb 27, 1989 | Substantially Equivalent |
| K884083 | TORAY VASCULAR PROSTHESIS | Jan 12, 1989 | Substantially Equivalent |
| K882158 | MODIFIED TORAY FILTRYZER DIALYZERS | Aug 12, 1988 | Substantially Equivalent |