Autologous Blood Processing System
FDA 510(k) K913181 · Lifestream Int'L, Inc.
510(k) numberK913181
Submission
- Device name
- Autologous Blood Processing System
- Applicant
- Lifestream Int'L, Inc.
The Woodlands, TX, US - Received
- July 18, 1991
- Decision date
- May 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K914396 | Surgi Light Non-Contact FibersGEX · Traditional | 12/23/1991SE |
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| K904491 | TMP Left Atrial Pressure Cath Cat.# 100-00X-000DQO · Traditional | 02/01/1991SE |
| K903709 | Surgimedics, SLP Laparoscopic Cholangiogram CathGBZ · Traditional | 10/26/1990SE |
Questions and answers
When was Autologous Blood Processing System cleared by the FDA?
Autologous Blood Processing System (K913181) received a 510(k) decision of Substantially Equivalent on May 20, 1992, 307 days after the submission was received.
What is the product code of K913181?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.