When did CELT ACD VASCULAR CLOSURE DEVICE receive FDA clearance or approval?

CELT ACD VASCULAR CLOSURE DEVICE (Submission ID: P150006) was fda approved by the U.S. FDA on 2026-10-30 under the PMA pathway with a review duration of 28 days.

Who is the manufacturer or applicant for CELT ACD VASCULAR CLOSURE DEVICE?

The applicant and sponsor for P150006 is Vasorum, Ltd..

Is P150006 an AI/ML-enabled medical device?

No. This medical device submission is not designated as incorporating AI/ML software algorithms.

FDA Approved Existing Device (Modification) Pathway: PMA

CELT ACD VASCULAR CLOSURE DEVICE

Applicant: Vasorum, Ltd.

Statutory Profile

Legal Standard:

Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)

Product Code:

MGB

Review Panel:

Cardiovascular

21 CFR Regulation:

Unspecified

Review Velocity Metrics

Date Received:

2026-10-02

Decision Date:

2026-10-30

Total Review Duration:

28 calendar days (28 days)

Official FDA Research Backlinks

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

FDA Database Webpage (pmn.cfm) Official Decision Summary PDF Product Classification Database Establishment Registration & Listing

Identified Contacts & Correspondents

James Coleman

Role: OFFICIAL_CORRESPONDENT

📞 353-1-4035460-465

Matt Dryden

Role: US_AGENT

📞 239-3076063

✉️ matt.dryden@promedic.cc

Notice a discrepancy or outdated information on this record?

Report to support@fdacleared.org