REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS— 510(k) K101789
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K101789 for REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS, Substantially Equivalent on 2010-08-19. Applicant: Sterilmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilmed, Inc.
- Product code
- Code NLH
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code NLH
view all- K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
- K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
- K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
More clearances from Sterilmed, Inc.
view all- K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more
- K190478 — Reprocessed ViewFlex Xtra ICE Catheter
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
- K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
Data sourced from openFDA. This site is unofficial and independent of the FDA.