Cryo Vascular Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cryo Vascular Systems, Inc.” (first 2002, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 5 | 5 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
Review panels
- Cardiovascular (7)
Most recent Cryo Vascular Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051916 | POLAR CATH PERIPHERAL DILATATION SYSTEM | LIT | 2005-08-05 | 21 |
| K042230 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM | DQY | 2004-11-05 | 80 |
| K042541 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM | DQY | 2004-10-12 | 22 |
| K033622 | POLARCATH PERIPHERAL DILATATION SYSTEM | DQY | 2004-02-10 | 84 |
| K030742 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM | LIT | 2003-08-29 | 172 |
| K023463 | CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT | DQY | 2003-02-19 | 127 |
| K022061 | CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER | DQY | 2002-09-20 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Cryo Vascular Systems, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cryo Corp. (3 510(k)s)
- Cryo Bio System (2 510(k)s)
- Cryo-Labs, Inc. (1 510(k)s)
- Cryo Therapy (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cryo Vascular Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Cryo Vascular Systems, Inc.” (first 2002, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cryo Vascular Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cryo Vascular Systems, Inc. is 84 days.
Which FDA product codes appear under Cryo Vascular Systems, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 5); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 2).
Next steps
- See all 7 Cryo Vascular Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Cryo Vascular Systems, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.