Liverty TIPS Access Set
FDA 510(k) K221440 · Bard Peripheral Vascular, Inc.
510(k) numberK221440
Submission
- Device name
- Liverty TIPS Access Set
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- May 17, 2022
- Decision date
- May 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Liverty TIPS Access Set cleared by the FDA?
Liverty TIPS Access Set (K221440) received a 510(k) decision of Substantially Equivalent on May 31, 2022, 14 days after the submission was received.
What is the product code of K221440?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.