FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FILTER, EXTRACORPOREAL BLOOD HOLDER
K Number: K781861
·
Decision Nov 15, 1978
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
41
Applicant Total
56
Review Days
9
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Basic Information
- Device Name
- FILTER, EXTRACORPOREAL BLOOD HOLDER
- K Number
- K781861
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Surgikos, Inc.
- Date Received
- November 6, 1978
- Decision Date
- November 15, 1978
- Product Code
- KRI
- 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 |
|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | FDA class 1 | Cardiovascular |
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Other Clearances by Surgikos, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875107 | HEALTH CARE EYE PROTECTION | Mar 21, 1988 | Substantially Equivalent |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Dec 30, 1987 | Substantially Equivalent |
| K861441 | NEUTRALON SURGICAL GLOVES | May 30, 1986 | Substantially Equivalent |
| K852870 | BARRIER SURGICAL GOWN | Jul 23, 1985 | Substantially Equivalent |
| K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION | Sep 30, 1982 | Substantially Equivalent |
| K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE | Jul 22, 1982 | Substantially Equivalent |
| K820542 | SURGIKOS INCISE DRAPE | Jun 2, 1982 | Substantially Equivalent |
| K811871 | BACTERICIDAL INCISE DRAPE | Aug 20, 1981 | Substantially Equivalent |
| K810316 | SURGIKOS FACE MASK | Feb 23, 1981 | Substantially Equivalent |
| K801864 | BARRIER APERTURED DRAPE | Aug 20, 1980 | Substantially Equivalent |