Angiosystems, Inc.
Ducktown, TN, US
ANGIOSYSTEMS, INC. appears in FDA device records in Ducktown, TN. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Angiosystems, Inc. between 1984 and 1991. The busiest year on record is 1991, with 8. The most recent is 1991, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 5 |
| 1987 | 1 |
| 1991 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K905464 | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | CBT | Unknown | |
| K905459 | SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM | LRO | Substantially Equivalent | |
| K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | EKS | Unknown | |
| K905466 | STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE | KKX | Substantially Equivalent | |
| K905465 | STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE | KKX | Substantially Equivalent | |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | LRP | Substantially Equivalent | |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | HMT | Substantially Equivalent | |
| K905463 | GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION | FOZ | Unknown | |
| K864688 | ARNOLD-KING PRESSURE DRESSING | NAD | Substantially Equivalent | |
| K843260 | ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE | KKX | Substantially Equivalent | |
| K843259 | ANGIO SYS FLUOROSCOPE DRAPE | Substantially Equivalent | ||
| K843258 | ANGIO SYS BRACHIAL ANGIO DRAPE | Substantially Equivalent | ||
| K843257 | ANGIO SYS STERILE FIELD COVER | Substantially Equivalent | ||
| K843261 | ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD | DRE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1037577 | 1037577 | ANGIOSYSTEMS, INC. | 7 HOPKINS PL., DUCKTOWN, TN 37326 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBTArterial Blood Sampling Kit
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DREDilator, Vessel, For Percutaneous Catheterization
- HMTDrape, Patient, Ophthalmic
- KKXDrape, Surgical, Antimicrobial
- NADDressing, Wound, Occlusive
- EKSFile, Pulp Canal, Endodontic
- LROGeneral Surgery Tray
- KPYShield, Protective, Personnel
- LRPTray, Surgical
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain