Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Angioslide, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
403 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172494 | PROTEUS PTA Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2017-12-15 | 119 | 0 |
| K133043 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | Angioslide, Ltd. | 2013-12-06 | 71 | 0 |
| K120164 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | Angioslide, Ltd. | 2012-06-08 | 141 | 0 |
| K120805 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | Angioslide, Ltd. | 2012-04-13 | 28 | 0 |
| K111750 | EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PRO | Angioslide, Ltd. | 2011-07-21 | 29 | 0 |
| K090364 | EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE | Angioslide, Ltd. | 2010-03-23 | 403 | 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