Resubmitted Micron Transfusion Filter
FDA 510(k) K873873 · Travenol Laboratories, S.A.
510(k) numberK873873
Submission
- Device name
- Resubmitted Micron Transfusion Filter
- Applicant
- Travenol Laboratories, S.A.
Round Lake, IL, US - Received
- August 31, 1987
- Decision date
- October 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAK – Microfilter, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K990310 | Charter Medical, Ltd MP 450 (40 Micron Filter)CAK · Traditional | Charter Medical, Ltd. | 08/30/1999SE |
| K982822 | Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric…CAK · Traditional | Baxter Healthcare Corp | 09/30/1998SE |
| K972159 | Fenwal 40 Micron Transfusion FilterCAK · Traditional | Baxter Healthcare Corp | 07/23/1997SE |
| K970225 | Alpha Micron 20/40 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/14/1997SE |
| K960993 | Pall SQ40S Blood Filter (SQ40S/SQ40ST)CAK · Traditional | Pall Biomedical Products Co. | 04/22/1996SE |
| K955515 | Alpha Micron 20 Microaggregate FilterCAK · Traditional | Alpha Therapeutic Corp. | 02/12/1996SE |
| K904223 | Sepacell(R) R-200/500 Leukocyte Removal Recip SetsCAK · Traditional | Baxter Healthcare Corp | 10/26/1990SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
| K873894 | Continu-Flo Solution W/Check Valve 2 Y-Inject SiteFPA · Traditional | 11/05/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | 10/13/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | 09/30/1987SE |
| K870801 | Flo-Gard 6200 Volumetric Infusion/Pumping BloodFRN · Traditional | 09/04/1987SE |
| K871908 | IV Administration SetBRZ · Traditional | 07/27/1987SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
| K870169 | Capillary Flow DialyzersFJI · Traditional | 04/06/1987SE |
Questions and answers
When was Resubmitted Micron Transfusion Filter cleared by the FDA?
Resubmitted Micron Transfusion Filter (K873873) received a 510(k) decision of Substantially Equivalent on October 22, 1987, 52 days after the submission was received.
What is the product code of K873873?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.