K212047 is an FDA 510(k) clearance for the Pantheris System. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.
Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 16, 2021 after a review of 139 days - within the typical 510(k) review window.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Avinger, Inc. devices
NCT03192696
Completed
Interventional
Industry-sponsored
Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries
INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries
| Condition studied |
Peripheral Arterial Disease |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Sean Janzer, MD |
| Sponsor |
Avinger, Inc.
(industry)
|
Started 2017-10-19
→
Primary completion 2021-06-01
→
Completed 2021-12-01
Primary outcome
Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety)
Secondary outcome
Stent structure freedom from new or worsening stent fracture post Pantheris treatment (safety)
Study completed - no results published.
This trial concluded in 2021 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov