Angiosystems, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Angiosystems, Inc.” (first 1984, latest 1991), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| HMT | Drape, Patient, Ophthalmic | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (5)
- General and Plastic Surgery (3)
- Anesthesiology (1)
- Cardiovascular (1)
- Dental (1)
Most recent Angiosystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905464 | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | CBT | 1991-05-31 | 177 |
| K905459 | SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM | LRO | 1991-04-05 | 121 |
| K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | EKS | 1991-03-05 | 90 |
| K905466 | STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE | KKX | 1991-02-11 | 68 |
| K905465 | STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE | KKX | 1991-02-11 | 68 |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | LRP | 1991-02-06 | 63 |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | HMT | 1991-02-06 | 63 |
| K905463 | GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION | FOZ | 1991-01-22 | 48 |
| K864688 | ARNOLD-KING PRESSURE DRESSING | NAD | 1987-01-12 | 41 |
| K843260 | ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE | KKX | 1984-09-21 | 32 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Angiosystems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Angiosystems, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Angiosystems, Inc.” (first 1984, latest 1991), across 10 product codes in 5 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 Angiosystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Angiosystems, Inc. is 56 days.
Which FDA product codes appear under Angiosystems, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 3); CBT (Arterial Blood Sampling Kit, 1); DRE (Dilator, Vessel, For Percutaneous Catheterization, 1).
Next steps
- See all 14 Angiosystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Angiosystems, 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.