22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car
FDA 510(k) K973713 · Cardiovascular Dynamics, Inc.
510(k) numberK973713
Submission
- Device name
- 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car
- Applicant
- Cardiovascular Dynamics, Inc.
Irvine, CA, US - Received
- September 29, 1997
- Decision date
- January 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K944016 | Focus Balloon Dilatation CatheterLIT · Traditional | 12/20/1994SE |
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Questions and answers
When was 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car cleared by the FDA?
22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car (K973713) received a 510(k) decision of Substantially Equivalent on January 23, 1998, 116 days after the submission was received.
What is the product code of K973713?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.