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FDA 510(k)

REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES

K-Number: K890453 · 1989-03-31

ApplicantDlp, Inc.
Decision Date1989-03-31
Product CodeDWZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1989-03-31 under 510(k) number K890453. The device is classified under product code DWZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES?

REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Dlp, Inc.. The 510(k) number is K890453.

When did REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES receive FDA 510(k) clearance?

REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES received FDA 510(k) clearance on 1989-03-31, under 510(k) number K890453.

Who is the listed applicant for REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES?

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

What is the FDA product code for REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES?

The FDA product code for REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES is DWZ.

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Other records listing Dlp, 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.

K973485CLEARVIEW BLOWER/MISTERK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETK950754MACRO SUCTION TUBE MODEL NO 10061K934215CONTAIN-ORK915268CATHETER TWO STAGE VENOUS RETURN

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Related Devices (Code: DWZ)

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.

K252722Biopsy ForcepsFehling Instruments GmbHK170726Biopsy ForcepsFehling Instruments GmbH & Co. KGK072051NOVATOME, MODEL: SU101-50Scholten Surgical Instruments, Inc.K010473SPARROWHAWK DISPOSABLEAtc Technologies, Inc.K000409MODIFICATION TO T-REX BIOPSY FORCEPSBoston Scientific CorpK991486ULTRA-CBXMedcanica, 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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