Device type
Catheter, Recording, Electrode, Reprocessed
Product code NLH · Class II · 21 CFR 870.1220 · Cardiovascular
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Recent 510(k)s
No 510(k) clearances in the archive for NLH.
Recent recalls
Oct 14, 2026
Z-0085-2027
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Stryker Sustainability Solutions
- NLH
- Class II
- Ongoing