Reprocessed Electrophysiology Diagnostic Catheters
FDA 510(k) K012523 · Sterilmed, Inc.
510(k) numberK012523
Submission
- Device name
- Reprocessed Electrophysiology Diagnostic Catheters
- Applicant
- Sterilmed, Inc.
Maple Grove, MN, US - Received
- August 6, 2001
- Decision date
- August 14, 2002
- 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 |
| K221854 | Reprocesses Umbilical CableNLH · Traditional | Innovative Health, LLC | 08/06/2022SE |
More from Innovative Health, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional | 06/29/2026SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | 10/11/2024SE |
| K190478 | Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | 11/14/2019SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | 04/15/2019SE |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional | 11/21/2016SE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional | 09/20/2016SE |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional | 06/23/2016SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | 03/23/2016SE |
| K152134 | Reprocessed Vessel SealerNUJ · Traditional | 01/15/2016SE |
Questions and answers
When was Reprocessed Electrophysiology Diagnostic Catheters cleared by the FDA?
Reprocessed Electrophysiology Diagnostic Catheters (K012523) received a 510(k) decision of Substantially Equivalent on August 14, 2002, 373 days after the submission was received.
What is the product code of K012523?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.