H/S CATHETER SET— 510(k) K032835
Substantially EquivalentCatheter Research, Inc.
FDA 510(k) clearance K032835 for H/S CATHETER SET, Substantially Equivalent on 2003-12-11. Applicant: Catheter Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Catheter Research, Inc.
- Product code
- Code LKF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code LKF
view allMore clearances from Catheter Research, Inc.
view allAdverse events under product code LKF
product code LKF- Malfunction
- 643
- Other
- 2
- Total
- 645
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 K032835
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032835.
Data sourced from openFDA. This site is unofficial and independent of the FDA.