Cardiotomy Reservoir W/20 Micron Filiter
FDA 510(k) K920178 · Lifestream Int'L, Inc.
510(k) numberK920178
Submission
- Device name
- Cardiotomy Reservoir W/20 Micron Filiter
- Applicant
- Lifestream Int'L, Inc.
The Woodlands, TX, US - Received
- January 14, 1992
- Decision date
- May 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
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| K904491 | TMP Left Atrial Pressure Cath Cat.# 100-00X-000DQO · Traditional | 02/01/1991SE |
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Questions and answers
When was Cardiotomy Reservoir W/20 Micron Filiter cleared by the FDA?
Cardiotomy Reservoir W/20 Micron Filiter (K920178) received a 510(k) decision of Substantially Equivalent on May 13, 1993, 485 days after the submission was received.
What is the product code of K920178?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.