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Rayflow RFW62U

by Hexacath

Rayflow RFW62U is a Class II device made by Hexacath, cleared under FDA 510(k) K222023 on 6 Apr 2023 and listed in FDA GUDID since 20 Jul 2023 (UDI-DI 03700385769154), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K222023

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700385769154 UDI-DI Date20 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222023 Date6 Apr 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222023 decided 6 Apr 2023 Active
  • FDA GUDID UDI-DI 03700385769154 listed 20 Jul 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222023
  2. Listed FDA GUDID 03700385769154

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rayflow
Generic name
Coronary artery infusion catheter
Model / reference
RFW62U
Primary DI / UDI-DI
03700385769154
510(k) Number
FDA product code
KRA, DQO
GMDN term
Coronary artery infusion catheter
Device class
Class II
Regulation number
870.1210, 870.1200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coronary artery infusion catheter

Other devices from Hexacath

See all devices from Hexacath →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (9, all answered No)