Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300
FDA 510(k) K133587 · St. Jude Medical Systems AB
510(k) numberK133587
Submission
- Device name
- Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300
- Applicant
- St. Jude Medical Systems AB
Westford, MA, US - Received
- November 21, 2013
- Decision date
- December 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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More from Cardioline S.P.A
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|---|---|---|
| K140466 | Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300DXO · Traditional | 11/13/2014SE |
| K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300DXO · Traditional | 09/05/2013SE |
| K111854 | Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, PW Usb ReceiverDRG · Traditional | 10/21/2011SE |
| K110193 | Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II…DXC · Special | 02/24/2011SE |
Questions and answers
When was Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300 cleared by the FDA?
Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300 (K133587) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 29 days after the submission was received.
What is the product code of K133587?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.