CAK · Microfilter, Blood Transfusion
General Hospital · 21 CFR 880.5440 · Class 2
Overview
| Product Code | CAK |
|---|---|
| Device Name | Microfilter, Blood Transfusion |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Classification Rationale
Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Special Controls
*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061103 | HAEMONETICS 40U RBC FILTER BAG | Haemonetics Corp. | May 17, 2006 | SESE |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | Summit Medical , Ltd. | Oct 25, 2002 | SESE |
| K000719 | NEOCARE 20 MICRON BLOOD FILTER | Whatman, Inc. | May 30, 2000 | SESE |
| K990310 | CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) | Charter Medical, Ltd. | Aug 30, 1999 | SESE |
| K982822 | FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 | Baxter Healthcare Corp | Sep 30, 1998 | SESE |
| K972159 | FENWAL 40 MICRON TRANSFUSION FILTER | Baxter Healthcare Corp | Jul 23, 1997 | SESE |
| K970225 | ALPHA MICRON 20/40 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | Feb 14, 1997 | SESE |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | Pall Biomedical Products Co. | Apr 22, 1996 | SESE |
| K955515 | ALPHA MICRON 20 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | Feb 12, 1996 | SESE |
| K904223 | SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS | Baxter Healthcare Corp | Oct 26, 1990 | SESE |
| K904221 | SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS | Baxter Healthcare Corp | Oct 26, 1990 | SESE |
| K901887 | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | Asahi Medical Co., Ltd. | Aug 8, 1990 | SESE |
| K896203 | SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER | Solco Basle, Inc. | Feb 1, 1990 | SESE |
| K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | Asahi Medical Co., Ltd. | Jan 24, 1990 | SESE |
| K896664 | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | Asahi Medical Co., Ltd. | Jan 24, 1990 | SESE |
| K890844 | MICROSEPT 60/20 | Arbor Technologies, Inc. | Jun 7, 1989 | SESE |
| K873792 | SEPACELL R-500 AND SEPACELL R-500A | Advocacy International, Ltd. | Jan 19, 1988 | SESE |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | Pall Biomedical Products Co. | Jan 6, 1988 | SESE |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | Pall Biomedical Products Co. | Jan 6, 1988 | SESE |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | Travenol Laboratories, S.A. | Oct 22, 1987 | SESE |
Top Applicants
- Abbott Laboratories — 4 clearances
- Baxter Healthcare Corp — 4 clearances
- Pall Biomedical Products Co. — 4 clearances
- Alpha Therapeutic Corp. — 3 clearances
- Asahi Medical Co., Ltd. — 3 clearances
