VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124— 510(k) K023140
Substantially EquivalentEpimed International, Inc.
FDA 510(k) clearance K023140 for VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124, Substantially Equivalent on 2003-08-15. 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
- Johnstown, 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 K023140
K-number listed on FDA's recall record- Z-2068-2019 — Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
- Z-2069-2019 — Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023140.
Data sourced from openFDA. This site is unofficial and independent of the FDA.