SHAPE MEMORY MEDICAL INC

FDA Device Registration & Listing · San Jose, CA, US · Registration 3013353964

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013353964
FEI Number
3013353964
Entity Name
SHAPE MEMORY MEDICAL INC
City/State/Country
San Jose, CA, US
Establishment Address
1321 Ridder Park Drive, Suite 10, San Jose, CA 95131, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shape Memory Medical Inc (Owner Number: 10055775)
Owner / Operator Contact Address
1321 Ridder Park Drive, Suite 10, San Jose, CA 95131, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181051
PMA Number
N/A

All Registered Proprietary Names

IMPEDE-FX Embolization Plug TrelliX Embolic Coil System IMPEDE-FX RapidFill IMPEDE Embolization Plug

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2019-10-07
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2018-10-12
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2017-10-05
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2018-07-23

Official Correspondent

Meghan Reu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Shape Memory Medical Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013353964. Last updated year: 2026. Please use registration number 3013353964 when referencing this establishment in official correspondence.
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