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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Vascular Solutions, LLC — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

164 daysmedian FDA review time
212 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); RingeVascular Solutions, LLC2024-05-311920
K230637Wattson temporary pacing guidewire (2250)Vascular Solutions, LLC2023-05-05590
K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); Vascular Solutions, LLC2022-08-181640
K221470Langston dual lumen catheterVascular Solutions, LLC2022-06-17280
K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catVascular Solutions, LLC2022-02-092090
K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit Vascular Solutions, LLC2022-02-092120
K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperVascular Solutions, LLC2021-04-30580
K193119Twin-Pass Dual Access CatheterVascular Solutions, LLC2020-06-292300
K200720D-Stat Radial Topical HemostatVascular Solutions, LLC2020-06-26990
K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold CVascular Solutions, LLC2019-08-09570
K182570Venture 0.014 CatheterVascular Solutions, LLC2019-03-131760

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda