swiftMATCH Coil, Soft 400SWSFT510

GUDID 00810169722190

swiftMATCH Coil, Soft, 5mm x 10cm

PENUMBRA, INC.

Non-neurovascular embolization coil
Primary Device ID00810169722190
NIH Device Record Keyef2f3002-00b0-459b-b295-0ac256924634
Commercial Distribution StatusIn Commercial Distribution
Brand NameswiftMATCH Coil, Soft
Version Model Number400SWSFT510-A
Catalog Number400SWSFT510
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810169722190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-03
Device Publish Date2026-01-26

On-Brand Devices [swiftMATCH Coil, Soft]

00810169722206swiftMATCH Coil, Soft, 5mm x 15cm
00810169722190swiftMATCH Coil, Soft, 5mm x 10cm
00810169722183swiftMATCH Coil, Soft, 4mm x 10cm
00810169722176swiftMATCH Coil, Soft, 4mm x 6cm
00810169722169swiftMATCH Coil, Soft, 3mm x 6cm

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.