Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Cryocath, LP — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
73 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2020-11-13 | 64 | 0 |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2018-11-26 | 10 | 0 |
| K163268 | FlexCath Select Steerable Shealth and Dilator | Medtronic Cryocath, LP | 2017-02-02 | 73 | 0 |
| K142684 | FlexCath Select Steerable Sheath (10 French) | Medtronic Cryocath, LP | 2014-11-06 | 48 | 1 |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Medtronic Cryocath, LP | 2012-12-27 | 36 | 0 |
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SH | Medtronic Cryocath, LP | 2010-09-01 | 29 | 1 |
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