Best Vascular, Inc.

Norcross, GA, US

BEST VASCULAR, INC. appears in FDA device records in Norcross, GA. FDA records list 5 510(k) clearances between 1988-08-09 and 1995-12-28, 49 PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 5
PMA records: 49
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Best Vascular, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Novoste Corp.510(k), recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Best Vascular, Inc. between 1988 and 1995. The busiest year on record is 1990, with 2. The most recent is 1995, with 1.

Clearances by year, as a table

510(k) clearance decisions for Best Vascular, Inc., by decision year
Year	Clearances
1988	1
1990	2
1991	1
1995	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K942977	NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE	DYB	Substantially Equivalent	1995-12-28
K911527	NOVOSTE GUIDING CATHETER	DQY	Substantially Equivalent	1991-04-24
K900460	MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER	DQO	Substantially Equivalent	1990-07-17
K896690	MODIFIED ANGIOGRAPHIC CATHETER	DQO	Substantially Equivalent	1990-01-24
K875127	NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS	DQO	Substantially Equivalent	1988-08-09

Registered establishments

FDA registered establishments for Best Vascular, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1062385	3000205626	BEST VASCULAR, INC.	4350 INTERNATIONAL BLVD., NORCROSS, GA 30093 US	2026	MOU

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0462-03	Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.	Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.		2002-01-25	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Best Vascular, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-06Source: openFDA, public domain