MX703 and MX730 Continuous Flush Devices
FDA 510(k) K961527 · Medex, Inc.
510(k) numberK961527
Submission
- Device name
- MX703 and MX730 Continuous Flush Devices
- Applicant
- Medex, Inc.
Dublin, OH, US - Received
- April 22, 1996
- Decision date
- June 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 MX703 and MX730 Continuous Flush Devices cleared by the FDA?
MX703 and MX730 Continuous Flush Devices (K961527) received a 510(k) decision of Substantially Equivalent on June 6, 1996, 45 days after the submission was received.
What is the product code of K961527?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.