DeviceClearance

Product code BTA— General, Plastic Surgery

605 VACU-MAX

Classification name
Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class 2
Regulation
21 CFR 878.4780
Advisory panel
General, Plastic Surgery
Total cleared
159
First cleared
Most recent

Market context for product code BTA

FDA has cleared 159 devices under product code BTA between 1979 and 2026, filed by 112 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code BTA

Adverse events under product code BTA

product code BTA
Death
5
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code BTA

1–100 of 159

Data sourced from openFDA. This site is unofficial and independent of the FDA.