Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocompatibles Cardiovascular, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970938 | HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE | Biocompatibles Cardiovascular, Inc. | 1997-11-17 | 249 | 0 |
| K962717 | 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOS | Biocompatibles Cardiovascular, Inc. | 1997-02-12 | 215 | 0 |
| K962266 | 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIA | Biocompatibles Cardiovascular, Inc. | 1996-09-10 | 90 | 0 |
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