REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER— 510(k) K112292
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K112292 for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER, Substantially Equivalent on 2011-10-21. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- 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
- Tempe, AZ, 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 Stryker Sustainability Solutions
view all- K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
- K250898 — Reprocessed HARMONIC 700 Shears (3 models)
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
- K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) +1 more
- K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) +1 more
Recalls naming K112292
K-number listed on FDA's recall record- Z-2268-2024 — Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
- Z-0766-2019 — BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
- Z-0467-2019 — Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
- Z-0916-2018 — Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.
- Z-0917-2018 — Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112292.
Data sourced from openFDA. This site is unofficial and independent of the FDA.