COMBICATH CATHETER— 510(k) K974642
Substantially EquivalentPlastimed Laboratoire Pharmaceutique
FDA 510(k) clearance K974642 for COMBICATH CATHETER, Substantially Equivalent on 1998-03-13. Applicant: Plastimed Laboratoire Pharmaceutique. Device class: 2.
Clearance details
- Applicant
- Plastimed Laboratoire Pharmaceutique
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code EOQ
view allMore clearances from Plastimed Laboratoire Pharmaceutique
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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 K974642
K-number listed on FDA's recall record- Z-2487-2020 — Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
- Z-2488-2020 — Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
- Z-2489-2020 — Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
- Z-2490-2020 — Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
- Z-2491-2020 — Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
- Z-2492-2020 — Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974642.
Data sourced from openFDA. This site is unofficial and independent of the FDA.