FDA 510(k)

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB

K-Number: K982797 · 1998-11-30

Decision Date1998-11-30

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB is the device name listed in this FDA 510(k) record. The listed applicant is Luther Medical Products, Inc.. It received FDA 510(k) clearance on 1998-11-30 under 510(k) number K982797. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB?

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB is a medical device that received FDA 510(k) clearance on 1998-11-30. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K982797.

When did BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB receive FDA 510(k) clearance?

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB received FDA 510(k) clearance on 1998-11-30, under 510(k) number K982797.

Who is the listed applicant for BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB?

The FDA 510(k) record lists Luther Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB?

The FDA product code for BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB is DYB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Luther Medical Products, Inc. as applicant

K980090ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)K974543L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER K940198L-CATH CONNECTOR ASSEMBLY K942103L-CATH CATHETER SYSTEM - PORT L-CATH K930473ONECATH L-CATH CATHETER SYSTEM K925236L CATH(R) CATHETER SYSTEM

View all 17 devices →

Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.