No. All NEScientific reprocessed devices are cleared by the FDA and have an FDA 510(K). Any reprocessed device purchased from NEScientific is considered by the FDA to be equivalent to a brand‐new device and held to the same quality and safety requirements of the FDA.
FAQs
Are NEScientific Reprocessed Devices illegal or pose any liability risk to me or my practice by using them?
How many times can a Philips IVUS catheter be reprocessed?
Once. Currently NEScientific does not reprocess multiple cycles for Philips IVUS.
How many times can a ClosureFast RF catheter be reprocessed?
Four times.
Should I send back catheters I purchased from NEScientific or only new catheters from the OEM?
Please send back ALL post procedure catheters, OEM devices and those purchased from NEScientific, using the prepaid labels and supplies NEScientific provides.
Will I have a specific Account Executive I can reach out to if I have any issues?
Yes. Please email or call to connect with the Account Executive that covers your geographical area. Sales@smarthealth‐care.com or 203‐756‐2111
What do I do If I have an issue with a catheter?
Save the catheter and send your Account Executive an email detailing the issue and NEScientific will send you a Return #. You will be issued a credit or replacement after the device is received and inspected by our Quality Engineers.