ReCross

EUDAMEDFDA UDIFDA 510(k)

Class III (EU MDR)

Ref RC1414025

by IMDS Operations B.V.

Identity

Trade Name: ReCross EUDAMEDFDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: ReCross OTW Dual Lumen Guide Wire Support Catheter EUDAMED
The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014” Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port. To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen FDA UDI
Model / Reference: RC1414025 EUDAMEDFDA UDI
Description: The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014” Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port. To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen FDA UDI

Identifiers

Catalog Number: RC1414025 FDA UDI
Primary DI / UDI-DI: 08718481740309 EUDAMEDFDA UDI
Basic UDI-DI: B-08718481740309 EUDAMED
510(k) Number: K210431 FDA UDI
FDA Product Code: DQY FDA UDI
EMDN Code: C0104010202 CARDIAC ANGIOGRAPHY GUIDE CATHETERS EUDAMED
GMDN Term: Vascular guide-catheter, single-use FDA UDI

Classification

Device Class: Class III EUDAMED
Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Market of Registration: Greece EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

ReCross by IMDS Operations B.V. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K210431	Class III	Active
EUDAMED	European Union	CE/MDD	B-08718481740309	Class III	Active

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Manufacturer

Manufacturer: IMDS Operations B.V.
EUDAMED SRN: NL-MF-000002065

Sources (3)

EUDAMED 2b30ab0b-bfc7-4734-8cd9-3e77c432e649 61 fields · synced Jun 19, 2026
FDA UDI 279532ff-506d-44a8-b9e2-71f6a68c37ee 35 fields · synced May 30, 2026
FDA 510(k) K210431 1 fields · synced May 18, 2026