DEVICE: HyperGlide (00763000294564)

Device Identifier (DI) Information

HyperGlide
104-4520
In Commercial Distribution

Micro Therapeutics, Inc.
00763000294564
GS1

1
826110710 *Terms of Use
BALLOON SYSTEM 104-4520 V20 HYPERGLIDE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32584 Intravascular occluding balloon catheter, image-guided
A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MJN Catheter, intravascular occluding, temporary
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K101570 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Special Storage Condition, Specify: This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C).
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2923fdcc-0013-486d-89ee-19e687d6c12c
May 26, 2025
3
August 01, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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