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

Cardiovascular Dynamics, Inc. — Predicate Candidate Screening

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

98 daysmedian FDA review time
202 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K97371322 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLECardiovascular Dynamics, Inc.1998-01-231160
K971577FOCUS-PV BALLOON DILATATION CATHETERCardiovascular Dynamics, Inc.1997-06-18580
K963989P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICECardiovascular Dynamics, Inc.1997-04-242020
K963688FOCUS PV BALLOON DILATATION CATHETERCardiovascular Dynamics, Inc.1997-03-281930
K945693CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETERCardiovascular Dynamics, Inc.1995-08-172690
K952064FOCUS BALLOON DILATATION CATHETERCardiovascular Dynamics, Inc.1995-06-21500
K951502CVD BULLET INFUSION CATYHETERCardiovascular Dynamics, Inc.1995-05-10430
K951503CVD BULLETT HI-FLO INFUSION CATHETERCardiovascular Dynamics, Inc.1995-05-04370
K944016FOCUS BALLOON DILATATION CATHETERCardiovascular Dynamics, Inc.1994-12-201260
K945465CVD SMALL VESSEL BALLOON DILATATION CATHETERCardiovascular Dynamics, Inc.1994-12-20430
K943023CVD BULLETT PERIPHERAL INFUSION CATHETERCardiovascular Dynamics, Inc.1994-09-30980

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