Minicrimp Carotid Patch Fabrics, Woven and Knitted

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

Full name

Woven and Knitted Minicrimp Carotid Patch Fabrics

510(k) Number

K905496 ↗

FDA Product Code

DXZ

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 Meadox Medicals, Div. Boston Scientific Corp. →

• What are the Minicrimp Carotid Patch Fabrics used for?

  These patches are designed specifically for carotid artery procedures, providing structural reinforcement and integration with biological tissue during surgical repair or reinforcement of the carotid artery. The woven and knitted construction ensures compatibility with vascular applications, helping to strengthen weakened arterial walls.

• Are the Minicrimp Carotid Patch Fabrics reusable or single-use?

  The Minicrimp Carotid Patch Fabrics are supplied as sterile, single-use devices. They are intended for one-time surgical use only and must not be reused after opening or exposure to non-sterile conditions. Reuse could compromise sterility and patient safety.

• What materials are used in the construction of these patches?

  The patches are manufactured from materials including polytetrafluoroethylene (PTFE), polyethylene terephthalate (PETP), and polypropylene. These materials are chosen for their compatibility with vascular applications and their ability to provide structural reinforcement while integrating with biological tissue.

• How should these patches be stored before use?

  The Minicrimp Carotid Patch Fabrics must be stored according to sterile medical device protocols. They should remain in their original, unopened packaging until immediately before use to maintain sterility. Exposure to moisture, heat, or contamination should be avoided.

• What regulatory clearance does this device have?

  The Minicrimp Carotid Patch Fabrics are cleared by the FDA under the 510(k) pathway with clearance number K905496. They fall under device classification DXZ and are categorized as Class II medical devices, indicating they pose moderate risk and require regulatory oversight.