Reprocesses Umbilical Cable
FDA 510(k) K221854 · Innovative Health, LLC
510(k) numberK221854
Submission
- Device name
- Reprocesses Umbilical Cable
- Applicant
- Innovative Health, LLC
Scottsdale, AZ, US - Received
- June 27, 2022
- Decision date
- August 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLH – Catheter, Recording, Electrode, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- 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).
Other 510(k)s with product code NLH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 11/26/2025SE |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 07/11/2025SE |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH · Traditional | Surgical Instrument Service and Savings, Inc. | 11/29/2024SE |
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…NLH · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 11/15/2024SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | Sterilmed, Inc. | 10/11/2024SE |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 09/14/2024SE |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 06/07/2024SE |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH · Traditional | Innovative Health | 06/07/2024SE |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterNLH · Traditional | Surgical Instrument Service and Savings, Inc. | 05/31/2023SE |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersNLH · Traditional | Innovative Health, LLC | 09/15/2021SE |
More from Innovative Health, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250305 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | 01/07/2026SE |
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersNLI · Traditional | 07/01/2024SE |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH · Traditional | 06/07/2024SE |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathPNE · Traditional | 04/04/2024SE |
| K230376 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | 08/07/2023SE |
| K213584 | Reprocessed NRG Transseptal NeedleQLZ · Traditional | 04/04/2023SE |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ · Traditional | 05/25/2022SE |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding SheathPNE · Traditional | 03/10/2022SE |
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledNLG · Traditional | 12/20/2021SE |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping CatheterNLG · Traditional | 11/18/2021SE |
Questions and answers
When was Reprocesses Umbilical Cable cleared by the FDA?
Reprocesses Umbilical Cable (K221854) received a 510(k) decision of Substantially Equivalent on August 6, 2022, 40 days after the submission was received.
What is the product code of K221854?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.