Cryocath Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cryocath Technologies, Inc.” (first 2003, latest 2008), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 59 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 3 | 3 |
| DRA | Catheter, Steerable | 2 | 2 |
| GEH | Unit, Cryosurgical, Accessories | 1 | 1 |
Review panels
Most recent Cryocath Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 | DRA | 2008-06-27 | 74 |
| K070357 | FLEXCATH STEERABLE SHEATH & DILATOR | DRA | 2007-12-28 | 324 |
| K062140 | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 | OCL | 2006-08-24 | 28 |
| K053436 | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | OCL | 2006-01-13 | 35 |
| K040690 | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | OCL | 2004-04-29 | 44 |
| K030303 | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE | GEH | 2003-04-29 | 90 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-08-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cryocath Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Cryocath Technologies, Inc.” (first 2003, latest 2008), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cryocath Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cryocath Technologies, Inc. is 59 days.
Which FDA product codes appear under Cryocath Technologies, Inc.?
The most frequent FDA product codes under this applicant name are OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, 3); DRA (Catheter, Steerable, 2); GEH (Unit, Cryosurgical, Accessories, 1).
Next steps
- See all 6 Cryocath Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCL, Cryocath Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.