EpiAccess System
FDA 510(k) K170831 · Epiep, Inc.
510(k) numberK170831
Submission
- Device name
- EpiAccess System
- Applicant
- Epiep, Inc.
New Haven, CT, US - Received
- March 20, 2017
- Decision date
- May 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142245 | EpiAccess SystemDYB · Traditional | 10/29/2014SE |
Questions and answers
When was EpiAccess System cleared by the FDA?
EpiAccess System (K170831) received a 510(k) decision of Substantially Equivalent on May 9, 2017, 50 days after the submission was received.
What is the product code of K170831?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.