Aries Taperseal Sheath

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

Full name

Aries Taperseal(Tm) Sheath

510(k) Number

K903442 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Aries 30cc & 50cc Intra-Aortic Balloon & Cont. Sys

  Class II

  FDA 510(k) K895433 Active Cleared 10 Apr 1990

• Aries Medical Perflex Percutaneous 40cc D/L Balloo

  Class II

  FDA 510(k) K844220 Active Cleared 20 Feb 1985

• 40cc Percutaneous Furl Single Intra-Aortic Balloon

  Class II

  FDA 510(k) K863185 Active Cleared 16 Jan 1987

• Epidural Catheter Tray

  Class II

  FDA 510(k) K840201 Active Cleared 2 Mar 1984

• Sjm/Cad Isoflow(Tm) Centrifugal Pump 2100CP, Modif

  Class II

  FDA 510(k) K912604 Active Cleared 28 Oct 1991

• 40cc Percutaneous Furl Dou. Lumen Balloon Catheter

  Class II

  FDA 510(k) K864567 Active Cleared 12 May 1987

See all devices from Aries Medical, Inc. →

• What is the Aries Taperseal Sheath used for?

  The Aries Taperseal Sheath is designed as a vascular introducer sheath to facilitate the insertion of catheters and instruments into blood vessels. Its tapered profile minimizes trauma to the vessel walls, which is particularly beneficial during interventional cardiology procedures like embolization coil placement. This design helps reduce complications and improves procedural safety.

• Is the Aries Taperseal Sheath intended for single-use or reuse?

  The Aries Taperseal Sheath is explicitly supplied as a single-use medical device. This classification ensures sterility and safety for each procedure, preventing cross-contamination and maintaining regulatory compliance. Single-use devices are typically discarded after one use to uphold infection control standards.

• What regulatory approval does the Aries Taperseal Sheath have?

  The Aries Taperseal Sheath has received FDA clearance under the 510(k) pathway with the clearance number K903442. This clearance was granted on August 23, 1990, and it is classified as substantially equivalent to a predicate device. The device is regulated under the Cardiovascular advisory committee and is intended for use in sterile environments.

• How is the Aries Taperseal Sheath supplied?

  The Aries Taperseal Sheath is supplied as a sterile, single-use device. Sterility is critical for vascular procedures to prevent infections, and the packaging ensures the device remains uncontaminated until use. Always follow manufacturer guidelines for opening and handling to maintain sterility.

• What sizes or models of the Aries Taperseal Sheath are available?

  The specifications provided do not detail specific sizes or models of the Aries Taperseal Sheath. For precise information on available sizes or models, refer to the manufacturer’s product catalog or technical documentation. This ensures you select the correct sheath for your procedural needs.