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

Bacchus Vascular, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time
198 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082199SPIRALFUSE PERIPHERAL INFUSION SYSTEMBacchus Vascular, Inc.2008-10-17740
K071664TRELLIS-6 PERIPHERAL INFUSION SYSTEMBacchus Vascular, Inc.2007-07-13252
K050147TRELLIS-8 PERIPHERAL INFUSION SYSTEMBacchus Vascular, Inc.2005-02-03100
K033997SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS Bacchus Vascular, Inc.2004-02-04420
K032261Trellis Reserve Infusion SystemBacchus Vascular, Inc.2003-08-22300
K022640SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 00Bacchus Vascular, Inc.2002-12-021160
K023514TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH Bacchus Vascular, Inc.2002-12-02421
K021958TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFBacchus Vascular, Inc.2002-07-03191
K013635TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUBacchus Vascular, Inc.2002-02-11980
K003570BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755Bacchus Vascular, Inc.2001-06-061980

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