Cleared Traditional

K090999 - BIOCARDIA MORPH SHEATH GUIDE

K090999 is an FDA 510(k) clearance for BIOCARDIA MORPH SHEATH GUIDE, manufactured by Biocardia, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K090999 · Biocardia, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
7d
Days
Class 2
Risk

K090999 is an FDA 510(k) clearance for the BIOCARDIA MORPH SHEATH GUIDE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Biocardia, Inc. (San Carlos, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K090999

510(k) Number K090999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2009
Decision Date April 15, 2009
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 705
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K090999.
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
K090114 · Oscor, Inc. · Jun 2009
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · Terumo Medical Corp. · May 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · St Jude Medical · Apr 2009
THE WAND MICROACCESS SAFETY INTRODUCER
K090372 · Access Scientific, Inc. · Mar 2009
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
K083855 · Acumen Medical, Inc. · Feb 2009
CROSSOVER
K083269 · Thomas Medical Products, Inc. · Feb 2009
K090999 · BIOCARDIA MORPH SHEATH GUIDE
Download PDF FDA Summary Biocardia, Inc.