CAK — Microfilter, Blood Transfusion Class II
FDA product code CAK covers "Microfilter, Blood Transfusion", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CAK
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K061103 | haemonetics | HAEMONETICS 40U RBC FILTER BAG | May 17, 2006 |
| K022477 | summit medical | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUS | October 25, 2002 |
| K000719 | whatman | NEOCARE 20 MICRON BLOOD FILTER | May 30, 2000 |
| K990310 | charter medical | CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) | August 30, 1999 |
| K982822 | baxter healthcare | FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PED | September 30, 1998 |
| K972159 | baxter healthcare | FENWAL 40 MICRON TRANSFUSION FILTER | July 23, 1997 |
| K970225 | alpha therapeutic | ALPHA MICRON 20/40 MICROAGGREGATE FILTER | February 14, 1997 |
| K960993 | pall biomedical products | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | April 22, 1996 |
| K955515 | alpha therapeutic | ALPHA MICRON 20 MICROAGGREGATE FILTER | February 12, 1996 |
| K904223 | baxter healthcare | SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS | October 26, 1990 |
| K904221 | baxter healthcare | SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS | October 26, 1990 |
| K901887 | asahi medical co | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | August 8, 1990 |
| K896203 | solco basle | SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER | February 1, 1990 |
| K896664 | asahi medical co | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | January 24, 1990 |
| K896976 | asahi medical co | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | January 24, 1990 |
| K890844 | arbor technologies | MICROSEPT 60/20 | June 7, 1989 |
| K873792 | advocacy international | SEPACELL R-500 AND SEPACELL R-500A | January 19, 1988 |
| K873666 | pall biomedical products | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | January 6, 1988 |
| K873667 | pall biomedical products | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | January 6, 1988 |
| K873873 | travenol laboratories | RESUBMITTED MICRON TRANSFUSION FILTER | October 22, 1987 |