Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vascular Solutions, Inc. — Predicate Candidate Screening
103 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
188 days90th percentile
103clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182232 | Octane Mechanical Thrombectomy System | Vascular Solutions, Inc. | 2018-09-11 | 25 | 0 |
| K181647 | Bandit guidewire | Vascular Solutions, Inc. | 2018-07-20 | 28 | 0 |
| K180913 | VSI Micro-Introducer Kit | Vascular Solutions, Inc. | 2018-05-09 | 30 | 0 |
| K180088 | TrapLiner catheter | Vascular Solutions, Inc. | 2018-04-04 | 82 | 0 |
| K180128 | Warrior 14 guidewire | Vascular Solutions, Inc. | 2018-02-16 | 30 | 0 |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (60 | Vascular Solutions, Inc. | 2018-01-19 | 29 | 0 |
| K173532 | Raider Guidewire | Vascular Solutions, Inc. | 2017-12-15 | 30 | 0 |
| K173266 | Octane aspiration system | Vascular Solutions, Inc. | 2017-12-01 | 51 | 0 |
| K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017-11-17 | 266 | 0 |
| K171946 | Gel-Bead | Vascular Solutions, Inc. | 2017-10-25 | 118 | 0 |
| K172090 | GuideLiner V3 Catheter | Vascular Solutions, Inc. | 2017-10-20 | 101 | 0 |
| K171335 | Venture 038 catheter | Vascular Solutions, Inc. | 2017-06-07 | 30 | 0 |
| K163307 | Expro Elite Snare, Sympro Elite Snare | Vascular Solutions, Inc. | 2017-03-08 | 105 | 0 |
| K161901 | TrapLiner catheter | Vascular Solutions, Inc. | 2017-02-03 | 207 | 0 |
| K162467 | Twin-Pass Torque | Vascular Solutions, Inc. | 2017-02-01 | 152 | 0 |
| K163444 | Spectre guidewire | Vascular Solutions, Inc. | 2017-01-06 | 29 | 0 |
| K161702 | Endura guidewire | Vascular Solutions, Inc. | 2016-12-06 | 169 | 0 |
| K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016-10-20 | 69 | 0 |
| K161336 | VSI StraitSet micro-introducer kit | Vascular Solutions, Inc. | 2016-08-11 | 90 | 0 |
| K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015-12-18 | 116 | 0 |
| K151234 | R350 guidewire | Vascular Solutions, Inc. | 2015-11-18 | 194 | 0 |
| K142065 | TURNPIKE CATHETER | Vascular Solutions, Inc. | 2014-11-25 | 118 | 0 |
| K143038 | Gel-Block 10X embolization pledgets | Vascular Solutions, Inc. | 2014-11-20 | 29 | 0 |
| K133237 | GEL-BEAD EMBOLIZATION SPHERES | Vascular Solutions, Inc. | 2014-04-25 | 186 | 0 |
| K132789 | FLIP INTRODUCER ACCESS KIT | Vascular Solutions, Inc. | 2014-04-17 | 223 | 0 |
| K133501 | LEADLINER CS LEAD DELIVERY SYSTEM | Vascular Solutions, Inc. | 2014-02-25 | 103 | 0 |
| K120707 | SWITCH-IT CATHETER | Vascular Solutions, Inc. | 2012-05-15 | 68 | 0 |
| K113266 | GEL-BLOCK EMBOLIZATION PLEDGETS | Vascular Solutions, Inc. | 2012-05-14 | 192 | 0 |
| K112100 | M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER | Vascular Solutions, Inc. | 2012-03-20 | 242 | 0 |
| K113140 | VARI-LASE WIREFIBER LASER FIBER | Vascular Solutions, Inc. | 2011-12-22 | 58 | 0 |
| K112082 | GUIDELINER V2 CATHETER | Vascular Solutions, Inc. | 2011-12-01 | 133 | 1 |
| K112631 | VSI GUIDEWIRE | Vascular Solutions, Inc. | 2011-10-27 | 48 | 0 |
| K112571 | XL EXTRACTION CATHETER | Vascular Solutions, Inc. | 2011-10-06 | 30 | 0 |
| K111334 | BENELLI ACCESS DEVICE | Vascular Solutions, Inc. | 2011-08-01 | 81 | 0 |
| K102212 | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP | Vascular Solutions, Inc. | 2011-04-08 | 245 | 0 |
| K101604 | VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7 | Vascular Solutions, Inc. | 2011-01-24 | 230 | 0 |
| K103405 | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CAT | Vascular Solutions, Inc. | 2010-12-22 | 33 | 1 |
| K101659 | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER | Vascular Solutions, Inc. | 2010-12-16 | 188 | 1 |
| K101625 | COHEN CROSSOVER CATHETER | Vascular Solutions, Inc. | 2010-07-19 | 40 | 0 |
| K100093 | VSI TORQUE DEVICE | Vascular Solutions, Inc. | 2010-04-30 | 107 | 0 |
| K093502 | VARI-LASE ENDOVENOUS LASER CONSOLE | Vascular Solutions, Inc. | 2010-01-07 | 56 | 0 |
| K092563 | GATOR CLIPSEAL PLUG | Vascular Solutions, Inc. | 2009-11-04 | 76 | 0 |
| K091750 | GUIDELINER CATHETER, MODELS 5571, 5572, 5573 | Vascular Solutions, Inc. | 2009-11-04 | 141 | 0 |
| K092612 | D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 | Vascular Solutions, Inc. | 2009-09-11 | 16 | 0 |
| K091551 | VARI-LASE PLATINUM BRIGHT TIP LASER FIBER | Vascular Solutions, Inc. | 2009-06-19 | 23 | 0 |
| K090977 | PIGGYBACK WIRE CONVERTER | Vascular Solutions, Inc. | 2009-06-18 | 73 | 0 |
| K091345 | GOPHER GOLD CATHETER, MODEL 5620 | Vascular Solutions, Inc. | 2009-06-12 | 37 | 0 |
| K083784 | PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTIO | Vascular Solutions, Inc. | 2009-03-30 | 101 | 0 |
| K081846 | GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 | Vascular Solutions, Inc. | 2009-01-28 | 212 | 0 |
| K082337 | MINNIE SUPPORT CATHETER | Vascular Solutions, Inc. | 2009-01-15 | 154 | 0 |
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