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FDA 510(k)

TUNNELING STYLET

K-Number: K882097 · 1988-07-28

ApplicantQuinton, Inc.
Decision Date1988-07-28
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TUNNELING STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K882097. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUNNELING STYLET?

TUNNELING STYLET is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Quinton, Inc.. The 510(k) number is K882097.

When did TUNNELING STYLET receive FDA 510(k) clearance?

TUNNELING STYLET received FDA 510(k) clearance on 1988-07-28, under 510(k) number K882097.

Who is the listed applicant for TUNNELING STYLET?

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

What is the FDA product code for TUNNELING STYLET?

The FDA product code for TUNNELING STYLET is DRB.

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Other records listing Quinton, Inc. 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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Related Devices (Code: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook IncorporatedK090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude MedicalK080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi

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.

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