Spectrax Implantable Pacemaker Pulse-Generator
510(k) K812153
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812153 | Date31 Aug 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Medtronic Spectrax
- 510(k) Number
- FDA product code
- DXY
- Device class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Spectrax is an Implantable Pacemaker Pulse-Generator, designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when necessary. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing, providing reliable pacing therapy to maintain normal heart function.
The device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings. It is classified as a Class III medical device under FDA regulations and has received FDA 510K clearance (K812153). The Spectrax is MRI-unsafe and must be handled with caution in magnetic environments. Storage and handling follow standard sterile implantable device protocols, adhering to manufacturer guidelines for longevity and performance.
Other devices from Medtronic Vascular, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of heart conditions is the Spectrax designed to treat, and how does it work?
The Spectrax is designed for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing. It works by delivering precise electrical impulses to the heart muscle, ensuring regular contractions and maintaining normal heart function when the natural pacemaker fails or is impaired.
Is the Spectrax intended for reuse, or is it meant to be implanted as a single-use device?
The Spectrax is supplied sterile and explicitly intended for single-use implantation only. It is not designed for reuse, and proper sterile handling protocols must be followed during and after implantation to ensure patient safety.
What precautions should be taken when handling the Spectrax, particularly in relation to magnetic fields?
The Spectrax is MRI-unsafe, meaning it should never be exposed to magnetic resonance imaging environments. Magnetic fields can interfere with its function or cause damage, posing risks to both the device and the patient. Always follow manufacturer guidelines for storage and handling to avoid magnetic exposure.
How should the Spectrax be stored before implantation, and what are the expected shelf-life considerations?
The Spectrax must be stored according to standard sterile implantable device protocols outlined by Medtronic. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until implantation to preserve sterility and performance. Follow the manufacturer’s instructions for longevity and proper storage conditions.
What regulatory pathway was followed for the Spectrax’s FDA clearance, and which committee reviewed it?
The Spectrax received FDA 510K clearance (K812153) through a traditional review pathway, classified as substantially equivalent to a predicate device. The Cardiovascular (CV) Advisory Committee reviewed the submission, and the device is categorized under product code DXY for Implantable Pacemaker Pulse-Generators.