FETH-R-KATH— 510(k) K981329
Substantially EquivalentEpimed International, Inc.
FDA 510(k) clearance K981329 for FETH-R-KATH, Substantially Equivalent on 1998-08-26. Applicant: Epimed International, Inc.. Device class: 2.
Clearance details
- Applicant
- Epimed International, Inc.
- Product code
- Code BSO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5120
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gloversville, NY, US
Recent devices under product code BSO
view allMore clearances from Epimed International, Inc.
view allAdverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
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 K981329
K-number listed on FDA's recall record- Z-2312-2021 — NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
- Z-2313-2021 — NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981329.
Data sourced from openFDA. This site is unofficial and independent of the FDA.