Directional Boot
by Pacesetter Systems 510(k)
Active
510(k) K813150
Overview
The Directional Boot is a component of an Implantable Pacemaker Pulse-Generator, designed to facilitate proper lead positioning and fixation within the cardiovascular system. It serves as a protective and anchoring mechanism to ensure stable attachment of the pacemaker lead during implantation procedures.
This device is supplied as a single-use component, intended for use in sterile surgical environments during pacemaker implantation. It is classified under FDA regulation number 870.3610 and was granted a Traditional 510(k) clearance through the Cardiovascular Advisory Committee in 1981. No additional sterility or MRI safety information is specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813150 | Date2 Dec 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Pacesetter Systems
Questions
What is the Directional Boot used for in a pacemaker procedure and how does it improve lead placement?
The Directional Boot is a protective and anchoring component designed to stabilize the pacemaker lead during implantation. It helps guide the lead into the correct position within the cardiovascular system and ensures secure fixation, reducing the risk of displacement or misplacement after the procedure.
Is the Directional Boot intended for reuse or is it meant to be used only once per patient?
The Directional Boot is explicitly supplied as a single-use component, meaning it is intended for use in one patient during a single surgical procedure. This ensures sterility and safety in sterile surgical environments.
What type of regulatory clearance does the Directional Boot hold, and how was it reviewed?
The Directional Boot holds a Traditional 510(k) clearance from the FDA, granted in 1981 through the Cardiovascular Advisory Committee. This means it was determined to be substantially equivalent to a legally marketed device at the time of review, under FDA regulation number 870.3610.
Does the Directional Boot come with any specific storage instructions or requirements?
While the provided data does not specify storage instructions, the Directional Boot is a single-use device intended for sterile surgical environments. It should be stored according to standard medical device guidelines to maintain sterility until use.