510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013005Substantially Equivalent

Act 11 Mp Ventricular Catheter

Innerspace, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013005 is the FDA 510(k) clearance record for ACT 11 MP VENTRICULAR CATHETER, a class II device, cleared for Innerspace, Inc. on under FDA product code HCA (Catheter, Ventricular). FDA records list 8 510(k) clearances for Innerspace, Inc., from to . As of , FDA records show no recalls naming K013005.

Clearance record

Decision date
Received
(183 days to decision)
Product code
HCA Catheter, Ventricular
Regulation
21 CFR 882.4100
Device class
Class II
Review panel
Neurology
Applicant
Innerspace, Inc. 2933 S. Pullman St.,, Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code HCA

Trailing 12 months

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

FDA records show no clearances under product code HCA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCA, 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