R501 – R502 Aortic Root Cannulae with and without Vent Line (R501-15, R501-20, R501-26; R502-15, R502-20, R502-26)

510(k) Number

K240193 ↗

FDA Product Code

DWF

Models / Variants

R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15

R502-20: R502-26)

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae

  Class II

  FDA 510(k) K972503 Active Cleared 26 Aug 1997

• Xtra

  Class II

  CE/MDR FDA 510(k) K112245 Active Cleared 6 Sep 2011

• XTRA Autotransfusion System (with XTRA Bowl sets)

  Class II

  FDA 510(k) K240584 Active Cleared 29 Apr 2024

• Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating

  Class II

  FDA 510(k) K061527 Active Cleared 27 Jun 2006

• Retrograde Cardioplegia Cannula, Manual-Inflating, with Malleable or Guidwire Stylet

  Class II

  FDA 510(k) K010974 Active Cleared 18 Jun 2001

• PureFlex Arterial Cannulae

  Class II

  FDA 510(k) K180979 Active Cleared 16 Nov 2018

See all devices from Sorin Group Italia S.R.L. →

• What are the key differences between the R501 and R502 aortic root cannulae, and how do I choose between them?

  The R501 and R502 cannulae share the same design purpose—facilitating arterial perfusion during cardiopulmonary bypass—but differ in whether they include an integrated vent line. The R501 models (R501-15, R501-20, R501-26) are designed without a vent line, while the R502 variants (R502-15, R502-20, R502-26) include one. Choose based on surgical requirements: opt for R502 if venting is needed to manage aortic root pressure or debris, and R501 if a simpler setup suffices. Both are single-use, sterile, and sized for compatibility with different patient anatomies.

• Are these cannulae reusable, or are they intended for single-use only?

  These cannulae are explicitly designed for single-use only in controlled surgical environments like operating rooms. The manufacturer’s instructions emphasize sterility and controlled use, so reuse is not recommended or supported. Discarding after one procedure ensures compliance with sterile field protocols and maintains patient safety.

• What sizes are available, and how do I determine the correct size for a patient?

  The cannulae come in three sizes for each variant: 15, 20, and 26. Selection depends on the patient’s aortic root diameter, which should be measured preoperatively. The R501-15/R502-15 is suited for smaller roots, while the R501-26/R502-26 accommodates larger anatomies. Consulting preoperative imaging or surgical guidelines ensures proper sizing to balance perfusion efficiency and vessel trauma.

• How should these cannulae be stored to maintain sterility and functionality?

  Storage requires protection from contamination and adherence to the manufacturer’s shelf-life guidelines. Keep the sterile packaging intact in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or chemical fumes, as these could compromise sterility or material integrity. Follow the expiration date on the packaging to ensure optimal performance.

• What regulatory pathway was followed for clearance of these devices, and what does that mean for clinicians?

  The R501–R502 cannulae received Special 510(k) clearance under the FDA’s Substantially Equivalent determination, classified as Class II devices. This means the FDA reviewed them against a predicate device (likely a similar aortic root cannula) to confirm safety and effectiveness for their intended use in cardiopulmonary bypass procedures. Clinicians can rely on this pathway as evidence of regulatory scrutiny, though local institutional protocols should still govern procurement and use.