Vanguard Reprocessed Diagnostic Electrophysiology Catheters
FDA 510(k) K051043 · Vanguard Medical Concepts, Inc.
510(k) numberK051043
Submission
- Device name
- Vanguard Reprocessed Diagnostic Electrophysiology Catheters
- Applicant
- Vanguard Medical Concepts, Inc.
Lakeland, FL, US - Received
- April 25, 2005
- Decision date
- June 6, 2005
- 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 |
|---|---|---|
| K053051 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 12/22/2005SE |
| K051616 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 09/06/2005SE |
| K051180 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 07/22/2005SE |
| K050763 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 06/01/2005SE |
| K043198 | Vanguard Reprocessed Arthroscopic WandsNUJ · Traditional | 05/27/2005SE |
| K043253 | Vanguard Reprocessed Dilating Tip and Blunt TrocarsNLM · Traditional | 04/08/2005SE |
| K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesNLM · Traditional | 03/31/2005SE |
| K043315 | Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelNLQ · Traditional | 03/22/2005SE |
| K043225 | Vanguard Reprocessed Ultrasonic ScalpelNLQ · Traditional | 03/22/2005SE |
| K040751 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 03/10/2005SE |
Questions and answers
When was Vanguard Reprocessed Diagnostic Electrophysiology Catheters cleared by the FDA?
Vanguard Reprocessed Diagnostic Electrophysiology Catheters (K051043) received a 510(k) decision of Substantially Equivalent on June 6, 2005, 42 days after the submission was received.
What is the product code of K051043?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.