Bipolar Stanicor Lambda Model 236, 235

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

510(k) Number

K790014 ↗

FDA product code

DXY

Device class

Class III

Regulation

21 CFR Part 870.3610

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

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See all devices from Cordis US Corp. →

• What is the primary purpose of the Bipolar Stanicor Lambda Model 236, 235 pacemaker, and how does it function in the body?

  The Bipolar Stanicor Lambda Model 236, 235 is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is intended for patients with abnormal heartbeats, such as bradycardia (slow heart rate), to help maintain a consistent and healthy heartbeat.

• Is this device intended for single-use or can it be reused after implantation?

  This device is explicitly supplied sterile and intended for single-use implantation only. It is not designed for reuse, as per its regulatory classification and intended use as a life-sustaining medical device.

• What regulatory pathway was followed for this device’s FDA clearance, and which advisory committee reviewed it?

  The Bipolar Stanicor Lambda Model 236, 235 was cleared under the FDA’s 510(k) pathway with a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed device. The Cardiovascular (CV) Advisory Committee reviewed the submission, as it falls under Cardiovascular Device Class 3, which includes life-supporting or life-sustaining devices.

• Are there multiple models (e.g., 235 vs. 236) of this device, and if so, how do they differ?

  The device listing includes two model variants: Model 235 and Model 236, though the provided data does not specify functional or technical differences between them. Both are classified as bipolar implantable pacemaker pulse-generators and share the same regulatory pathway and clearance (K790014). Confirmation of model-specific features would require consulting the manufacturer’s technical documentation.

• How should this device be stored before implantation, and what precautions should be taken?

  As a sterile, single-use device, the Bipolar Stanicor Lambda Model 236, 235 should be stored in its original packaging according to the manufacturer’s instructions to maintain sterility. Avoid exposure to moisture, extreme temperatures, or physical damage, as these could compromise its integrity before use. Always follow Cordis Corp.’s storage guidelines to ensure proper functionality and safety.