Cleared Traditional

K240787 - Selectra 3D Lead Delivery System (443624-443629, 451789-451791) (FDA 510(k) Clearance)

Also includes:
Selectra Slitter Tool (383119) Selectra Accessory Kit (375518)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K240787 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
174d
Days
Class 2
Risk

K240787 is an FDA 510(k) clearance for the Selectra 3D Lead Delivery System (443624-443629, 451789-451791). Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 12, 2024 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K240787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2024
Decision Date September 12, 2024
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04323670 Completed Interventional Industry-sponsored

Master Study Investigating the Guiding Catheter Selectra 3D

BIO|MASTER.Selectra 3D Study

157
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Pacemaker DDD
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Uwais Mohamed, PhD
Sponsor Biotronik SE & Co. KG (industry)
Started 2020-10-08 → Primary completion 2022-12-22
Primary outcome
Selectra 3D-related SADE-free rate
Secondary outcome
Successful implantation rate
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQY Catheter, Percutaneous

All 887
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K240787.
Amplatzer TorqVue Delivery System
K260993 · Abbott · Apr 2026
Teleport Glide Microcatheter
K253361 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Apr 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · Abbott Medical · Mar 2026
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025
Telescope Guide Extension Catheter
K252390 · Medtronic, Ireland · Oct 2025