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FDA 510(k)

MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT

K-Number: K875327 · 1988-03-25

ApplicantSchneider-Shilley (Usa)
Decision Date1988-03-25
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Schneider-Shilley (Usa). It received FDA 510(k) clearance on 1988-03-25 under 510(k) number K875327. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT?

MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT is a medical device that received FDA 510(k) clearance on 1988-03-25. The listed applicant is Schneider-Shilley (Usa). The 510(k) number is K875327.

When did MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT receive FDA 510(k) clearance?

MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT received FDA 510(k) clearance on 1988-03-25, under 510(k) number K875327.

Who is the listed applicant for MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT?

The FDA 510(k) record lists Schneider-Shilley (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT?

The FDA product code for MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT is DRE.

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Other records listing Schneider-Shilley (Usa) 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.

K882826SOFTRAC-PTA PERIPHERAL DILATATION CATHETERK875175MODIFIED PERIPHERAL DILATATION CATHETERSK881197SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETERK875322MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETERK875323MODIFIED SCHNEIDER-SHILEY WIRE TORQUERK875324MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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