FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K251970

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Device Name

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Manufacturer

Medtronic, Ireland

Date Cleared

2026-01-17

(205 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K251744

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Device Name

Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter

Manufacturer

Medtronic

Date Cleared

2026-01-16

(224 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K251831

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Device Name

Bio-Medicus Life Support Catheter and Introducer

Manufacturer

Medtronic, Inc.

Date Cleared

2026-01-15

(216 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253470

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Device Name

MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)

Manufacturer

Medtronic Minimed, Inc.

Date Cleared

2026-01-15

(97 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253511

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Device Name

Concerto Versa Detachable Coil

Manufacturer

Medtronic, Inc.

Date Cleared

2026-01-14

(70 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253585

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Device Name

SmartGuard technology; Predictive Low Glucose technology

Manufacturer

Medtronic Minimed, Inc.

Date Cleared

2026-01-14

(58 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253512

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Device Name

MiniMed Go App

Manufacturer

Medtronic Minimed

Date Cleared

2026-01-08

(63 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253941

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Device Name

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)

Manufacturer

Medtronic Sofamor Danek USA, Inc.

Date Cleared

2026-01-07

(29 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253409

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Device Name

C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)

Manufacturer

Medtronic, Inc.

Date Cleared

2025-12-19

(80 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

K250558

Predicate For

N/A

Intended Use

This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

Device Description

The C320LBB delivery system is composed of a single-use, disposable, fixed-shape catheter with integrated hemostasis valve, two integrated radiopaque marker bands at the distal segment and a dilator. These components are used together to provide a flexible and hemostatic conduit for insertion of intravascular devices into the right chambers of the heart.

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K Number

K252390

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Device Name

Telescope Guide Extension Catheter

Manufacturer

Medtronic Ireland

Date Cleared

2025-10-29

(90 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

K183353

Predicate For

N/A

Intended Use

Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Device Description

The Telescope™ Guide Extension Catheter is a single-lumen rapid exchange catheter designed to act as an extension to a traditional guide catheter. The Telescope™ Guide Extension Catheter is intended to be used with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The Telescope™ Guide Extension Catheter device is 150cm in length and consists of a hydrophilic-coated single-lumen distal guide segment connected to a stainless-steel polytetrafluoroethylene (PTFE) coated proximal pushwire.

The device is offered in two sizes 6F and 7F, with a hub at the proximal end of the pushwire that is used for device identification.

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