Swan-Ganz CC0/SVO2 Thermodilution Catheter
FDA 510(k) K940795 · Baxter Edwards
510(k) numberK940795
Submission
- Device name
- Swan-Ganz CC0/SVO2 Thermodilution Catheter
- Applicant
- Baxter Edwards
Irvine, CA, US - Received
- February 22, 1994
- Decision date
- May 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYG – Catheter, Flow Directed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1240
- Specialty
- Cardiovascular
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| K081052 | Occlusion Balloon Catheter, Model VenosDYG · Traditional | Oscor, Inc. | 06/18/2008SE |
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| K944214 | Baxter Handle Model 1150DTJ · Traditional | 02/10/1995SE |
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Questions and answers
When was Swan-Ganz CC0/SVO2 Thermodilution Catheter cleared by the FDA?
Swan-Ganz CC0/SVO2 Thermodilution Catheter (K940795) received a 510(k) decision of Substantially Equivalent on May 24, 1994, 91 days after the submission was received.
What is the product code of K940795?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.