---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-032150"
form_type: "8-K"
ticker: "NUWE"
cik: "0001506492"
company_name: "Nuwellis, Inc."
filed_at: "2025-08-21T23:59:59+00:00"
generated_at: "2026-05-17T10:48:33.125804+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Nuwellis gets FDA 510(k) clearance for new catheter size

## Summary
- FDA 510(k) clearance received for new size of Nuwellis' Dual Lumen Extended Length Catheter (dELC) on August 21, 2025.
- Clearance allows Nuwellis to market the new size catheter in the United States.
- No specific dimensions, commercial launch date, or revenue impact disclosed.

## SEC filing metadata
- accession: 0001140361-25-032150
- form_type: 8-K
- ticker: NUWE
- cik: 0001506492
- company_name: Nuwellis, Inc.
- filed_at: 2025-08-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1506492/000114036125032150/0001140361-25-032150-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1506492/000114036125032150/ef20054300_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-032150
- JSON: https://secwatch.observer/filing/0001140361-25-032150.json
- Plain text: https://secwatch.observer/filing/0001140361-25-032150.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.