Product code NMK— Cardiovascular

Reprocessed BRK Transseptal Needle

Classification name: Trocar, Reprocessed
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Total cleared: 1
First cleared: 2020-07-22
Most recent: 2020-07-22

FDA classification definition

“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).”
— U.S. Food and Drug Administration, device classification record for product code NMK under 21 CFR 870.1390, via openFDA

Market context for product code NMK

FDA has cleared 1 device under product code NMK, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NMK

Innovative Health, LLC1 clearance

Recent clearances under product code NMK

K192998 — Reprocessed BRK Transseptal NeedleInnovative Health, LLC·2020-07-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.