CATH BELT PD CATHETER AND TRANSFER SET HOLDER— 510(k) K930175
Substantially EquivalentTabex Industries, Inc.
FDA 510(k) clearance K930175 for CATH BELT PD CATHETER AND TRANSFER SET HOLDER, Substantially Equivalent on 1994-06-23. Applicant: Tabex Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Tabex Industries, 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
- Memphis, TN, US
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- K130441 — FALLER STYLET
- K121383 — PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
- K120130 — FALLER TROCAR
More clearances from Tabex Industries, 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.