Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6
FDA 510(k) K133157 · Medtronic, Inc.
510(k) numberK133157
Submission
- Device name
- Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6
- Applicant
- Medtronic, Inc.
Minneapolis, MN, US - Received
- October 17, 2013
- Decision date
- October 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
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Questions and answers
When was Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6 cleared by the FDA?
Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6 (K133157) received a 510(k) decision of Substantially Equivalent on October 23, 2014, 371 days after the submission was received.
What is the product code of K133157?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.