Dacron Pledget Suture Buttress

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K812254 ↗

FDA product code

DXZ

FDA applicant

ETHICON, Inc.

Device class

Class II

Regulation

21 CFR Part 870.3470

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

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See all devices from Ethicon Inc. →

• What materials are the Dacron Pledget Suture Buttress made from, and how does this affect its use in cardiovascular procedures?

  The Dacron Pledget Suture Buttress is constructed from materials like polypropylene, polyethylene terephthalate (Dacron), or polytetrafluoroethylene (PTFE). These materials provide structural reinforcement and stability to sutures during cardiovascular surgeries, such as repairing septal defects or patch grafting. The choice of materials ensures durability and compatibility with intracardiac tissues, reducing the risk of suture failure or displacement.

• Are these pledgets reusable, or are they intended for single-use only? How should they be stored?

  The Dacron Pledget Suture Buttress is supplied in sterile, single-use configurations, meaning each package is intended for one surgical procedure only. To maintain sterility, they should be stored in their original packaging, protected from moisture, extreme temperatures, and direct sunlight. Proper storage ensures the device remains uncontaminated and ready for use in the operating room.

• What sizes are available for the Dacron Pledget Suture Buttress, and how do I determine the right size for a procedure?

  The device comes in specific dimensions tailored to procedural needs, such as 7mm × 7mm × 1.5mm or 9.5mm × 4.8mm × 1.5mm. The correct size depends on the anatomical requirements of the patient and the surgical technique being used. Consulting preoperative imaging or working closely with the surgical team to assess defect size or graft requirements will help select the appropriate pledget dimensions.

• Can the Dacron Pledget Suture Buttress be used with MRI imaging, or are there any restrictions?

  The device is explicitly not intended for MRI use, as stated in the manufacturer’s documentation. This restriction is due to the potential risks associated with magnetic fields interacting with the materials used in the pledget, which could cause heating or displacement. Always verify imaging compatibility with the surgical team before or after use.

• What regulatory pathway does the Dacron Pledget Suture Buttress follow, and what does this mean for clinicians?

  The device was cleared through the FDA’s 510(k) pathway under the classification of a Class II medical device, with a decision described as Substantially Equivalent to a predicate device. This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for intracardiac reinforcement procedures. Clinicians can trust that it meets established regulatory standards for use in cardiovascular surgeries.