CATHETER, BETA-CAP-PERITONEAL— 510(k) K782058
Substantially EquivalentDravon Medical, Inc.
FDA 510(k) clearance K782058 for CATHETER, BETA-CAP-PERITONEAL, Substantially Equivalent on 1979-02-27. Applicant: Dravon Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Dravon Medical, Inc.
- Product code
- Code FJS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FJS
view all- K213602 — Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
- K180485 — Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
- K130441 — FALLER STYLET
- K121383 — PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
- K120130 — FALLER TROCAR
More clearances from Dravon Medical, Inc.
view allAdverse events under product code FJS
product code FJS- Death
- 34
- Injury
- 652
- Malfunction
- 576
- Other
- 6
- Total
- 1,268
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.