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Route 92 Medical, Inc. devices, product family

by Route 92 Medical, Inc. 7 variants Basic UDI-DI 0853799007NRSEC

Shared by every variant

Manufacturer
Route 92 Medical, Inc.(7)
Basic UDI-DI
0853799007NRSEC
Risk class
Class III
Legislation
MDR
EMDN category
MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMSCARDIAC ANGIOGRAPHY GUIDE CATHETERS
Market status
7 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 0853799007NRSEC.

Certificates

2 certificates naming this Basic UDI-DI · EUDAMED

  • 1000209962 Technical documentation · refdata.applicable-legislation.mdr issued
    Notified body 0297 · holder Route 92 Medical, Inc. · issued 10 Mar 2025 · expires 7 Oct 2029
  • 1000236584 Quality management system · refdata.applicable-legislation.mdr supplemented
    Notified body 0297 · holder Route 92 Medical, Inc. · issued 16 May 2025 · expires 18 May 2027

Recalls

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 7 devices listed on this page; other pages of the family can carry others.

Variants

7 devices · page 1 of 1

Variants of Route 92 Medical, Inc. devices, Basic UDI-DI 0853799007NRSEC
UDI-DISize and differences
FreeClimb 54 Reperfusion Catheter (x125cm) with Tenzing 5 7001-54-125R-EU00853799007817 —On the market
FreeClimb 54 Reperfusion Catheter with Tenzing 5 7001-54-148R-EU00853799007800 —On the market
FreeClimb 70 reperfusion catheter with Tenzing 7 7001-70-132R-EU00853799007565 —On the market
FreeClimb 88 reperfusion catheter (x125cm) with Tenzing 8 7001-88-125R-EU00853799007589 —On the market
FreeClimb 88 reperfusion catheter (x132cm) with Tenzing 8 7001-88-132R-EU00853799007602 —On the market
HiPoint 70 reperfusion catheter with Tenzing 7 2004-70-142R-EU00853799007428 —On the market
HiPoint 88 reperfusion catheter with Tenzing 8 2004-88-143R-EU00853799007305 —On the market