Reprocessed BRK Transseptal Needle
FDA 510(k) K192998 · Innovative Health, LLC
510(k) numberK192998
Submission
- Device name
- Reprocessed BRK Transseptal Needle
- Applicant
- Innovative Health, LLC
Scottsdale, AZ, US - Received
- October 28, 2019
- Decision date
- July 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NMK – Trocar, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- 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).
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Questions and answers
When was Reprocessed BRK Transseptal Needle cleared by the FDA?
Reprocessed BRK Transseptal Needle (K192998) received a 510(k) decision of Substantially Equivalent on July 22, 2020, 268 days after the submission was received.
What is the product code of K192998?
The FDA product code is NMK – Trocar, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1390.