SWAN VALLEY MEDICAL, INCORPORATED

FDA Device Registration & Listing · Denver, CO, US · Registration 3009688853

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
3009688853
FEI Number
3009688853
Entity Name
SWAN VALLEY MEDICAL, INCORPORATED
City/State/Country
Denver, CO, US
Establishment Address
4246 Carson St Unit 102, Denver, CO 80239, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Swan Valley Medical, Incorporated (Owner Number: 10041114)
Owner / Operator Contact Address
4246 Carson Street - Suite 102, Denver, CO 80239, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K120127
PMA Number
N/A

All Registered Proprietary Names

T-SPeC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FEX Instrument, Catheter, Punch Gastroenterology, Urology Class 1 876.5090 2017-11-20
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2017-11-20

Official Correspondent

Kathie Lapcevic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Swan Valley Medical, Incorporated
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
K132890 Mediplus , Ltd. SUPRAPUBIC CATHETER AND INTRODUCER SET 2014-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009688853. Last updated year: 2026. Please use registration number 3009688853 when referencing this establishment in official correspondence.
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