Cg+ Arrow Jacc Powered by Arrow VPS Stylet
FDA 510(k) K132133 · Arrow International (Subsidiary of Teleflex Inc.)
510(k) numberK132133
Submission
- Device name
- Cg+ Arrow Jacc Powered by Arrow VPS Stylet
- Applicant
- Arrow International (Subsidiary of Teleflex Inc.)
Reading, PA, US - Received
- July 11, 2013
- Decision date
- September 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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Questions and answers
When was Cg+ Arrow Jacc Powered by Arrow VPS Stylet cleared by the FDA?
Cg+ Arrow Jacc Powered by Arrow VPS Stylet (K132133) received a 510(k) decision of Substantially Equivalent on September 26, 2013, 77 days after the submission was received.
What is the product code of K132133?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.