Chase Medical, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Chase Medical, Inc.” (first 1997, latest 2007), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 97 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 15 | 15 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 7 | 7 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| FQH | Lavage, Jet | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 | 1 |
Review panels
- Cardiovascular (24)
- Radiology (3)
- General Hospital (2)
Most recent Chase Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072473 | CHASE MR SYSTEM | LNH | 2007-12-10 | 97 |
| K062031 | CHASE CARDIAC ANALYSIS SYSTEM | LLZ | 2006-09-27 | 71 |
| K032531 | CHASE CARDIAC ANALYSIS SYSTEM | LLZ | 2004-02-02 | 171 |
| K022093 | CHASE CARDIOVASCULAR PATCH KIT | DXZ | 2002-09-20 | 85 |
| K021129 | CHARE CARIOVASCULAR PATCH | DXZ | 2002-06-03 | 56 |
| K020233 | CHASE CARDIOVASCULAR PATCH KIT | DXZ | 2002-03-14 | 50 |
| K020132 | CHASE CARDIOVASCULAR PATCH KIT | DXZ | 2002-02-26 | 42 |
| K012248 | CHASE CARDIOVASCULAR PATCH | DXZ | 2001-08-10 | 24 |
| K003467 | CHASE CARDIOVASCULAR PATCH | DXZ | 2001-01-29 | 82 |
| K001662 | CHASE CARDIOVASCULAR PATCH | DXZ | 2000-08-02 | 63 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chase Medical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Chase Medical, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
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.
- Chase Mfg. Co. (10 510(k)s)
- Chase Medical Services (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chase Medical, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Chase Medical, Inc.” (first 1997, latest 2007), across 8 product codes in 3 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 Chase Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chase Medical, Inc. is 97 days.
Which FDA product codes appear under Chase Medical, Inc.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 15); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 7); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 29 Chase Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Chase Medical, 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.