510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K030627Substantially Equivalent

Orbiter Pv Diagnostic Electrode Catheter, Models 320100 & 320110

C.R. Bard Inc, Lowell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030627 is the FDA 510(k) clearance record for ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K030627.

Clearance record

Decision date
Received
(238 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 55 Technology Dr., Lowell MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRF

Trailing 12 months
2 clearances under product code DRF in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRF, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260