Crosspoint Transaccess Catheter, Model TA-XP-001
FDA 510(k) K031920 · Trans Vascular Incorporated
510(k) numberK031920
Submission
- Device name
- Crosspoint Transaccess Catheter, Model TA-XP-001
- Applicant
- Trans Vascular Incorporated
Menlo Park, CA, US - Received
- June 23, 2003
- Decision date
- July 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Crosspoint Transaccess Catheter, Model TA-XP-001 cleared by the FDA?
Crosspoint Transaccess Catheter, Model TA-XP-001 (K031920) received a 510(k) decision of Substantially Equivalent on July 23, 2003, 30 days after the submission was received.
What is the product code of K031920?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.