FDA.reportPublic FDA data

PROVISIO MEDICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30161719423016171942PROVISIO MEDICAL INC.1N2026-01-0110815 Rancho Bernardo Rd Suite 110 San Diego CA US 92127

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850045446000SLT IVUS P1 Pulser Receiver Unit - See LBL-0998, SLT IVUS P1 System Manual858-524-3901info@provisiomedical.com
00850045446024SLT IVUS Support Crossing Catheter - The SLT IVUS Support Crossing Catheters are over-the-wire intravascular ultrasound catheters with a digital ultrasound transducer array at the distal end that also functions as support crossing catheter.858-524-3901info@provisiomedical.com
00850045446031SLT IVUS P1 Display Unit - See LBL-0998, SLT IVUS P1 System Manual858-524-3901info@provisiomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3281431322390769K233948Provisio™ SLT IVUS™ SystemOBJ2024-04-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBJ12024-04-23

PMN#

GUDID#