510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073664Substantially Equivalent

Frontline Medical Safetynet Guidewire Introducer

Injectimed, Inc., Albuquerque NM / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073664 is the FDA 510(k) clearance record for FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER, a class I device, cleared for Injectimed, Inc. on under FDA product code MDM (Instrument, Manual, Surgical, General Use). FDA records list 3 510(k) clearances for Injectimed, Inc., from to . As of , FDA records show no recalls naming K073664.

Clearance record

Decision date
Received
(226 days to decision)
Product code
MDM Instrument, Manual, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Injectimed, Inc. 5616 Mariola Pl. NE, Albuquerque NM
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MDM

Trailing 12 months

FDA records hold no clearances under product code MDM in the trailing twelve months.

FDA records show no clearances under product code MDM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MDM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260