Swan-Ganz Intellicath Cco Thermodilution Catheter
FDA 510(k) K924661 · Baxter Healthcare Corp
510(k) numberK924661
Submission
- Device name
- Swan-Ganz Intellicath Cco Thermodilution Catheter
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- September 15, 1992
- Decision date
- April 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
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Questions and answers
When was Swan-Ganz Intellicath Cco Thermodilution Catheter cleared by the FDA?
Swan-Ganz Intellicath Cco Thermodilution Catheter (K924661) received a 510(k) decision of Substantially Equivalent on April 8, 1993, 205 days after the submission was received.
What is the product code of K924661?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.