Liberator Beacon Tip Locking Stylet
FDA 510(k) K170298 · Cook Incorporated
510(k) numberK170298
Submission
- Device name
- Liberator Beacon Tip Locking Stylet
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- January 31, 2017
- Decision date
- October 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRB – Stylet, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1380
- Specialty
- Cardiovascular
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Questions and answers
When was Liberator Beacon Tip Locking Stylet cleared by the FDA?
Liberator Beacon Tip Locking Stylet (K170298) received a 510(k) decision of Substantially Equivalent on October 18, 2017, 260 days after the submission was received.
What is the product code of K170298?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.