Dravon Medical, Inc.
Clackamas, OR, US
DRAVON MEDICAL, INC. appears in FDA device records in Clackamas, OR. FDA records list 16 510(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 16 510(k) clearances for Dravon Medical, Inc. between 1977 and 1987. The busiest year on record is 1977, with 4. The most recent is 1987, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 4 |
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 3 |
| 1983 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K873455 | S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS | FJK | Substantially Equivalent | |
| K860770 | AM-100 I/A AMPAC | HQC | Substantially Equivalent | |
| K832739 | STEDIFLO INFUSION SET | LDR | Substantially Equivalent | |
| K831842 | DRAVON T CLAMP | KDC | Substantially Equivalent | |
| K812772 | PERITONEAL DIALYSIS CYCLER SET (8UNIT) | KDJ | Substantially Equivalent | |
| K812771 | PERITONEAL DIALYSIS DRAINAGE | KDJ | Substantially Equivalent | |
| K811851 | S-610 SHUNT ADAPTOR SET | KNR | Substantially Equivalent | |
| K800435 | HEMOSTATIC/TUBE OCCLUDING FORCEPS | GEN | Substantially Equivalent | |
| K782058 | CATHETER, BETA-CAP-PERITONEAL | FJS | Substantially Equivalent | |
| K782057 | CATHETER, RADIOPAQUE TENCKHOFF | FJS | Substantially Equivalent | |
| K781755 | DAP-PAK | KDJ | Substantially Equivalent | |
| K780079 | CANNULA, ARTERY, RENAL | DQR | Substantially Equivalent | |
| K771097 | FORCEP, DISP., A CLAMP | HTD | Substantially Equivalent | |
| K760952 | TERASAKI LYMPHOCYTE TRANSPORT KIT | KSR | Substantially Equivalent | |
| K760995 | DECOLLATING TRAY | FJZ | Substantially Equivalent | |
| K760994 | MONITOR LINE W/FILTER & NEEDLE | KOC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021643 | 3021643 | DRAVON MEDICAL, INC. | 11465 SE Highway 212, Clackamas, OR 97015 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KNRAdapter, A-V Shunt Or Fistula
- DQRCannula, Catheter
- FJSCatheter, Peritoneal, Long-Term Indwelling
- HXDClamp
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- LDRController, Infusion, Intravascular, Electronic
- FJZDeclotting Tray, Kit (Including Contents)
- HTDForceps
- GENForceps, General & Plastic Surgery
- KDCInstrument, Surgical, Disposable
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- HQCUnit, Phacofragmentation
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