Swank Blood Transfusion Micro-Filter W/Straight Se
FDA 510(k) K855064 · Cobe Laboratories, Inc.
510(k) numberK855064
Submission
- Device name
- Swank Blood Transfusion Micro-Filter W/Straight Se
- Applicant
- Cobe Laboratories, Inc.
Lakewood, CO, US - Received
- December 18, 1985
- Decision date
- March 12, 1986
- 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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| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
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Questions and answers
When was Swank Blood Transfusion Micro-Filter W/Straight Se cleared by the FDA?
Swank Blood Transfusion Micro-Filter W/Straight Se (K855064) received a 510(k) decision of Substantially Equivalent on March 12, 1986, 84 days after the submission was received.
What is the product code of K855064?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.