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FDA 510(k)

HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS

K-Number: K982313 · 1998-08-10

ApplicantWeck Closure Systems
Decision Date1998-08-10
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS is the device name listed in this FDA 510(k) record. The listed applicant is Weck Closure Systems. It received FDA 510(k) clearance on 1998-08-10 under 510(k) number K982313. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS?

HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS is a medical device that received FDA 510(k) clearance on 1998-08-10. The listed applicant is Weck Closure Systems. The 510(k) number is K982313.

When did HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS receive FDA 510(k) clearance?

HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS received FDA 510(k) clearance on 1998-08-10, under 510(k) number K982313.

Who is the listed applicant for HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS?

The FDA 510(k) record lists Weck Closure Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS?

The FDA product code for HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS is FZP.

Related Clinical Trials

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Other records listing Weck Closure Systems as applicant

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.

K011660WECK CARDIAC PACING WIRESK003337HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240K993157HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240K982944HEM-O-LOCK, MODEL 523935K982941HEM-O-LOK MODEL NUMBERS 523900, 523970

Related Devices (Code: FZP)

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.

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

Official Source

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

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