FLEX-NECK PD CATHETER, INFANT— 510(k) K031351
Substantially EquivalentMedigroup, Inc.
FDA 510(k) clearance K031351 for FLEX-NECK PD CATHETER, INFANT, Substantially Equivalent on 2003-09-17. Applicant: Medigroup, Inc.. Device class: 2.
Clearance details
- Applicant
- Medigroup, 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
- Naperville, 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 Medigroup, 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 →
Recalls naming K031351
K-number listed on FDA's recall record- Z-1143-2018 — Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
- Z-1144-2018 — Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
- Z-1145-2018 — Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031351.
Data sourced from openFDA. This site is unofficial and independent of the FDA.