Sterile Packaging

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

510(k) Number

K810410 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

• Implantable Electrode Lead, Model 030-446

  Class III

  FDA 510(k) K874664 Active Cleared 31 May 1988

See all devices from Telectronics, Inc. →

• What types of implantable pacemaker pulse-generators is this sterile packaging designed to protect?

  This sterile packaging is specifically designed to protect and maintain the sterility of implantable pacemaker pulse-generators. It is intended for use in sterile operating environments like cardiac catheterization labs or surgical suites to ensure contamination control during storage and transport.

• Is this sterile packaging reusable, or is it meant for single-use only?

  The sterile packaging is explicitly labeled as a single-use item. It is not designed for reuse, and each package should be discarded after one use to maintain sterility and integrity.

• How should this sterile packaging be stored to ensure it remains sterile and intact before use?

  The sterile packaging must be stored according to the manufacturer’s guidelines to preserve sterility and integrity. While the exact storage instructions are not detailed here, it is critical to follow the provided instructions to avoid compromising the sterile barrier before use.

• What regulatory pathway was followed for this sterile packaging, and which advisory committee was involved?

  This sterile packaging received a Traditional 510(k) clearance under the FDA’s regulatory pathway, specifically reviewed by the Cardiovascular (CV) advisory committee. The clearance was granted in 1981, confirming its compliance with FDA standards for protecting implantable pacemaker pulse-generators.

• Where is this sterile packaging manufactured, and what is the manufacturer’s address?

  This sterile packaging is manufactured by Telectronics, Inc., located at 803 N. Front St. Suite 3, McHenry, IL 60050, USA. The address reflects the applicant’s headquarters for regulatory submissions.