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

Intervascular, Inc. — Predicate Candidate Screening

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

97 daysmedian FDA review time
337 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990800INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN Intervascular, Inc.2001-01-086700
K984294MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROIntervascular, Inc.1999-02-22830
K983819INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT Intervascular, Inc.1998-11-24261
K970843INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESESIntervascular, Inc.1997-06-05900
K964625HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCUIntervascular, Inc.1997-05-051712
K921659ULTRA LOW POROSITY DACRON WOVEN PATCHIntervascular, Inc.1992-11-252320
K913143OCHSNER ULP BIFURCATION VASCULAR PROTHESISIntervascular, Inc.1991-10-23990
K912911LOW POROSITY (LP) VASCULAR PROSTHESISIntervascular, Inc.1991-09-23830
K905269OCHSNER 500 VASCULAR PROSTHESISIntervascular, Inc.1991-04-021300
K905270OCHSNER 50 VASCULAR PROSTHESISIntervascular, Inc.1991-02-15840
K903964OCHSNER 50 BIFURCATIONIntervascular, Inc.1990-12-03970
K881508OCHSNER & MICRON FABRIC PATCHIntervascular, Inc.1988-05-25440
K870884RADIALLY-SUPPORTED VASCULAR PROSTHESESIntervascular, Inc.1988-02-053370
K862739INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESESIntervascular, Inc.1986-08-21310
K854845INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULARIntervascular, Inc.1986-08-182570
K833716LP200 & HP800 SERIES VASCULAR PROSTHIntervascular, Inc.1984-01-10810

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