PPD BALLOON DILATATION CATHETER— 510(k) K020379
Substantially EquivalentTelemed Systems, Inc.
FDA 510(k) clearance K020379 for PPD BALLOON DILATATION CATHETER, Substantially Equivalent on 2002-05-06. Applicant: Telemed Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Telemed Systems, Inc.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hudson, MA, US
Recent devices under product code KNT
view allMore clearances from Telemed Systems, Inc.
view all- K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
- K010412 — FLEXIBLE ENDOSCOPIC SCISSORS
- K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
- K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
- K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.