Atlas FDA

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

Boston Scientific /International Technologies · Predicate Candidate Screening

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

210 daysmedian FDA review time
392 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971688IVT 0.014 PTFE-COATED TRACKWIREBoston Scientific /International Technologies1997-12-112180
K96366311F GUIDING CATHETERBoston Scientific /International Technologies1997-01-131220
K954552RAILWIREBoston Scientific /International Technologies1996-04-292100
K954622IVT 0.014 TRACK OR IVT 0.014 ACCUTRACKBoston Scientific /International Technologies1996-04-292070
K930808PROTECTOR INTRODUCER SHEATHBoston Scientific /International Technologies1994-03-153920

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