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

Scimed Peripheral Interventions — Predicate Candidate Screening

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

115 daysmedian FDA review time

168 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K945904	SCIMED(R) VENTURE(TM) II INFUSION CATHETER	Scimed Peripheral Interventions	1995-05-19	168
K946272	SCIMED(R) COURIER GUIDE CATHETER	Scimed Peripheral Interventions	1995-04-17	115
K944677	SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES	Scimed Peripheral Interventions	1995-02-08	139
K941710	SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES	Scimed Peripheral Interventions	1994-09-01	148
K935501	SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING	Scimed Peripheral Interventions	1994-01-27	72
K934793	SCIMED MAVERICK	Scimed Peripheral Interventions	1994-01-05	91
K934122	SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES	Scimed Peripheral Interventions	1993-10-07	43
K934359	SCIMED STRIKE STEERABLE GUIDE WIRE	Scimed Peripheral Interventions	1993-10-07	29

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